This document provides an overview of the Global Food Safety Initiative (GFSI) and compares various GFSI-recognized food safety standards. The GFSI aims to improve food safety, reduce audits, and increase transparency through a benchmarking process. It recognizes several standards that meet its criteria for ensuring safe food production globally. The document analyzes key standards like BRC, FSSC 22000, IFS Food, SQF 2000, and GLOBALG.A.P., comparing their requirements, certification processes, and suitability for different organizations. It also discusses potential benefits of combining standards to conduct a single audit addressing multiple needs.
1. The document discusses management strategies for veterinary medicinal products in aquaculture, focusing on tilapia farms.
2. It emphasizes establishing a veterinary health program (VHP) using Hazard Analysis and Critical Control Points (HACCP) principles to control hazards like improper drug use. This involves forming a team, conducting risk assessments, setting critical limits, monitoring procedures, corrective actions, and record keeping.
3. Third party certification audits are recommended to help the seafood industry improve practices and assure consumers, though most current aquaculture production is not certified due to the large number of small-scale farms.
#InvitroStudies are critical to the #drug and #wellness product #development due to their ability to provide a basis for #clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. #Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology #development of the active process, when the selectively and possible interactions of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established. Our team can provide solution map on case to case basis for your specific requirement . For more details please visit on https://www.stabicon.com/In-Vitro.php
Getting Started with GFSI (For Manufacturers)TraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Meeting Description:
Being compliant with a Global Food Safety Initiative (GFSI) recognized scheme can be a business accelerator, but is also often viewed as a daunting task. It doesn’t need to be.
Join our webinar to learn about the impetus for creating the GFSI, its benefits, and basic steps to get you going on the process to becoming compliant.
Karil Kochenderfer, GFSI’s North American representative, will start with an overview of the Global Food Safety Initiative and its benefits.
John Kukoly, Director of BRC in the Americas, will then give a general overview of what is required to begin the compliancy process with any GFSI-compliant scheme relevant to food manufacturers and ingredient processors.
Topics to be addressed:
-Why certification to a GFSI scheme matters to you
-Considerations in choosing a scheme
-The audit process explained
-Best practices for successful implementation
-Poor practices to avoid
-Key areas to focus on in planning and implementation
The webinar will conclude with both Karil and John taking questions from the audience.
About the Global Food Safety Initiative:
The Global Food Safety Initiative is a business-driven initiative for the continuous improvement of food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide. GFSI provides a platform for collaboration between some of the world's leading food safety experts from retailer, manufacturer and food service companies, service providers associated with the food supply chain, international organizations, academia and government.
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
Introduction to GFSI Schemes - SAI GlobalRowenaCurtis1
Today’s food supply chain presents complex challenges, and many of the world’s largest food retailers are mandating supplier certification to Global Food Safety Initiative (GFSI) schemes.
This is the slide deck from SAI Global's Webinar with Senior Safety Consultant, Dr Bob Strong who gives an overview of the GFSI-recognised schemes - BRC, FSSC 22000, IFS Food, SQF Code, and Global G.A.P. The webinar provides you with an overview of GFSI schemes, their key differences, how to select the right standard for your organization, and tips on becoming certified.
________________________________________
- Frontage is a fully integrated global CRO providing drug development services including medicinal chemistry, preclinical and clinical testing, bioanalytical services, pharmacology, and regulatory support.
- They have facilities in the US, China, and other locations around the world to offer regional clinical trials and laboratory services.
- Frontage offers a wide range of services from early drug discovery through commercialization including API synthesis, formulation development, clinical trials, and regulatory filings with global health authorities.
1. The document discusses the implementation of ICH Q7 guidelines for quality management systems for APIs. It focuses on key sections like quality management, responsibilities of quality units, production activities, and internal audits.
2. Internal audits are described as an important management tool to evaluate compliance with GMP principles and identify additional requirements for continuous improvement.
3. Efficient internal audits require trained auditors from different departments along with quality unit representation, though the quality unit coordinates all audit activities.
1. The document discusses management strategies for veterinary medicinal products in aquaculture, focusing on tilapia farms.
2. It emphasizes establishing a veterinary health program (VHP) using Hazard Analysis and Critical Control Points (HACCP) principles to control hazards like improper drug use. This involves forming a team, conducting risk assessments, setting critical limits, monitoring procedures, corrective actions, and record keeping.
3. Third party certification audits are recommended to help the seafood industry improve practices and assure consumers, though most current aquaculture production is not certified due to the large number of small-scale farms.
#InvitroStudies are critical to the #drug and #wellness product #development due to their ability to provide a basis for #clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. #Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology #development of the active process, when the selectively and possible interactions of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established. Our team can provide solution map on case to case basis for your specific requirement . For more details please visit on https://www.stabicon.com/In-Vitro.php
Getting Started with GFSI (For Manufacturers)TraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Meeting Description:
Being compliant with a Global Food Safety Initiative (GFSI) recognized scheme can be a business accelerator, but is also often viewed as a daunting task. It doesn’t need to be.
Join our webinar to learn about the impetus for creating the GFSI, its benefits, and basic steps to get you going on the process to becoming compliant.
Karil Kochenderfer, GFSI’s North American representative, will start with an overview of the Global Food Safety Initiative and its benefits.
John Kukoly, Director of BRC in the Americas, will then give a general overview of what is required to begin the compliancy process with any GFSI-compliant scheme relevant to food manufacturers and ingredient processors.
Topics to be addressed:
-Why certification to a GFSI scheme matters to you
-Considerations in choosing a scheme
-The audit process explained
-Best practices for successful implementation
-Poor practices to avoid
-Key areas to focus on in planning and implementation
The webinar will conclude with both Karil and John taking questions from the audience.
About the Global Food Safety Initiative:
The Global Food Safety Initiative is a business-driven initiative for the continuous improvement of food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide. GFSI provides a platform for collaboration between some of the world's leading food safety experts from retailer, manufacturer and food service companies, service providers associated with the food supply chain, international organizations, academia and government.
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
Introduction to GFSI Schemes - SAI GlobalRowenaCurtis1
Today’s food supply chain presents complex challenges, and many of the world’s largest food retailers are mandating supplier certification to Global Food Safety Initiative (GFSI) schemes.
This is the slide deck from SAI Global's Webinar with Senior Safety Consultant, Dr Bob Strong who gives an overview of the GFSI-recognised schemes - BRC, FSSC 22000, IFS Food, SQF Code, and Global G.A.P. The webinar provides you with an overview of GFSI schemes, their key differences, how to select the right standard for your organization, and tips on becoming certified.
________________________________________
- Frontage is a fully integrated global CRO providing drug development services including medicinal chemistry, preclinical and clinical testing, bioanalytical services, pharmacology, and regulatory support.
- They have facilities in the US, China, and other locations around the world to offer regional clinical trials and laboratory services.
- Frontage offers a wide range of services from early drug discovery through commercialization including API synthesis, formulation development, clinical trials, and regulatory filings with global health authorities.
1. The document discusses the implementation of ICH Q7 guidelines for quality management systems for APIs. It focuses on key sections like quality management, responsibilities of quality units, production activities, and internal audits.
2. Internal audits are described as an important management tool to evaluate compliance with GMP principles and identify additional requirements for continuous improvement.
3. Efficient internal audits require trained auditors from different departments along with quality unit representation, though the quality unit coordinates all audit activities.
The document discusses ICH Q7 guidelines for good manufacturing practices for active pharmaceutical ingredients. ICH Q7 provides guidance on GMP for manufacturing APIs to ensure quality, safety and efficacy. It covers requirements for facilities, equipment, documentation, materials management, production, packaging, labeling, testing, validation, and quality management. Adhering to ICH Q7 helps ensure consistent API quality and reduces batch variations.
ICH 7- GMP Guidance for API-questions & answersMD. SELIM REZA
This document provides clarification on uncertainties regarding the interpretation of certain sections of the ICH Q7 guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients. It answers questions on applying GMP to manufacturing steps before and after the defined API starting material. It also addresses questions on applying GMP to steps that add substances to stabilize an API, and clarifies that ICH Q7 should be applied to mixtures classified as an API.
Our leading-edge manufacturing facilities located in Southern California allow PYRAMID to offer the pharmaceutical and biotech industries a wide range of services including aseptic vial and syringe filling, as well as lyophilization capabilities, for both Clinical and Commercial products.
Vskills certification for Biopharmaceutical Professional assesses the candidate as per the company’s need for developing and managing biopharmaceuticals. The certification tests the candidates on various areas in types, sources of biopharmaceuticals which also includes methods of production and legal issues.
http://www.vskills.in/certification/Health-Nutrition-and-Well-being/Certified-Biopharmaceutical-Professional
This presentation discusses the revision of the FDA's Question-based Review (QbR) system for generic drug submissions. The QbR questions were revised to fully incorporate quality-by-design (QbD) elements like quality target product profiles and critical quality attributes. Key changes include removing questions answered with 'refer to DMF' and revising 'yes/no' questions. The revised QbR aims to facilitate a more science- and risk-based review of generic drug applications and further encourage QbD principles. A mock application and FAQ are in development to aid understanding of the new QbR. Feedback on the revised questions is welcome.
This document discusses ICH Q7 and Q11 guidelines for good manufacturing practices for active pharmaceutical ingredients. It defines key terms like starting material and active pharmaceutical ingredient. It also discusses characteristics that must be evaluated for active pharmaceutical ingredients like elucidation of structure, impurities, specifications and analytical validation. The document contrasts traditional and enhanced approaches to development and manufacturing under ICH Q11, noting the traditional approach relies on set points, operating ranges and release based on meeting criteria, while the enhanced approach uses greater science and risk knowledge to identify critical quality attributes and develop a control strategy.
This document discusses Good Manufacturing Practices (GMP) for pharmaceutical products as outlined by the World Health Organization (WHO). It provides definitions and explanations of key GMP concepts including quality assurance, quality management, and ensuring consistent production of pharmaceuticals according to appropriate quality standards. It also discusses WHO involvement in establishing GMP guidelines and differences between GMP and current Good Manufacturing Practice (cGMP). The document outlines basic GMP principles for quality management, sanitation, qualification and validation, complaints and recalls, and more. It emphasizes that quality failures can result in regulatory warnings, market withdrawals, supply disruptions, and loss of credibility with patients and regulators.
The document summarizes the BRC Global Standard for Storage and Distribution. It was introduced in 2006 and last updated in 2010 to complement other BRC global standards. The primary objective is to maintain food safety and quality as products move through the supply chain. The standard aims to complete the chain between manufacturers and retailers. Audits last 1.5 days on average and assess non-conformities, with corrective actions required to achieve certification. Requirements address issues like hazard analysis, quality management, facilities, vehicles, operations, and training.
Pharmaceutical Industry Departments roles and responsibilities manasa life sc...ManasaLifeSciencesMa
Pharmaceutical Industry Departments and its roles and responsibilities were discussed. Product selection, Development, Manufacturing, Product approval, Marketing
Stabicon Life Sciences is a contract research organization located in Bangalore, India. It was established in 2010 and is approved by regulatory agencies in India, Canada, and the US. The company offers formulation development, analytical testing, stability studies, and other CRO services. It has a dedicated cGMP and cGLP compliant laboratory with experienced professionals and facilities for method development, validation, microbiology testing, and more. Stabicon aims to deliver high quality services to pharmaceutical clients at competitive costs while maintaining confidentiality and assisting throughout product development and registration.
Introduction of training on pharmaceutical quality system Dr.Milind Pathak
The document provides information about a training on pharmaceutical quality systems organized by Quality Circle Forum of India (QCFI). QCFI is a non-profit organization that provides training to professionals at different levels in industries. The Ankleshwar chapter of QCFI has launched activities like 6-month evening coaching and campus training programs on pharmaceutical quality systems and regulatory guidelines for pharmaceutical industries. The training modules will cover topics like cGMP, documentation, sanitation, validations, quality risk management and ICH guidelines. The training will be participatory in nature followed by an evaluation test, and certificates will be distributed. It will be conducted by Dr. Milind Pathak, who has 29 years of experience in quality assurance, quality systems and
The document discusses ICH Q7, a guideline for good manufacturing practices for active pharmaceutical ingredients. It aims to improve quality, enhance productivity and effectiveness of API manufacturing. ICH Q7 applies to APIs made through chemical synthesis, extraction, fermentation or combinations and establishes requirements for quality management, personnel, facilities, equipment, documentation, materials management, production controls, packaging and more. Adherence to ICH Q7 helps ensure APIs are safe, effective and of good quality and prepared according to cGMP standards expected by regulatory agencies like the FDA.
Good Manufacturing Practice (GMP) 2day course Jo Havemann
The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions
Industry Program In Pharma Quality Assurance And Quality Controlbiinoida
The document describes an industry program in pharmaceutical quality assurance and quality control offered through distance learning. The 12-month program aims to enhance knowledge of quality professionals and provide in-depth training in areas like GMP, quality assurance, regulation, and statistics. Participants can pursue careers in quality assurance, control, engineering, and management and work for major pharmaceutical companies upon completion.
New PDA/IPEC Technical Report on Excipient Risk Assessment - insights for dru...MilliporeSigma
Access the interactive recording: https://bit.ly/37HqbTK
Abstract:
Since March 2016 the EU Guideline to ascertain the appropriate GMP for pharmaceutical excipients is legally binding. Although the EU Guideline itself provides a high level description how to perform the risk assessment, the implementation can be challenging. In January 2018 PDA and IPEC formed a joint Task Force with the objective to develop a joint Technical Report to share best practices with industry. This Technical Report was published in December 2019. In this webinar you will be introduced to the new Technical Report, its objective, proposed approaches and examples shared by PDA/IPEC member companies.
This document provides an introduction and overview of a training session on Good Manufacturing Practices (GMP) for the 21st century. It notes that the presentation will reflect the presenter's views and is not meant to represent any official policies. Examples of recent drug contamination and mix-ups are presented to illustrate the importance of GMP in ensuring consistent quality, preventing contamination and mix-ups. GMP is described as a set of regulatory methods to inspect manufacturing practices to protect the integrity and quality of products intended for human use and ensure they are consistently produced and controlled.
Tackling the challenges of single-use manufacturing for ADCsMilliporeSigma
Watch the full webinar here: https://bit.ly/2Ix3uud
In this webinar, you will learn:
• How SU assemblies are used in the ADC development space
• Recommendations for consistent transfer of SU processes to manufacturing
• Understand if SU technology is right for your product
• Evaluate the pros and cons of SU for ADCs
Antibody Drug Conjugates (ADCs) are a class of biomolecules that has seen rapid growth with multiple new commercial products in 2020. Adoption of SU systems has been slow due to concerns for safe handling of organic solvents and the toxic small molecule payload. Recent advances in Single-use technology have overcome these concerns and now provide understanding of the suitability, scalability, and fluid compatibility of both the single-use components as well as the supporting hardware and controls. In this webinar, we show how the single-use technology can deliver consistent and scalable ADC chemistry and functionality with desired final product specifications and high yield.
This document provides an overview of post-marketing surveillance requirements for drug products. It discusses general reporting requirements including field alert reports, annual reports, labeling changes, and adverse event reporting. The key aspects of post-marketing surveillance are monitoring adverse drug reactions, ensuring compliance with manufacturing standards, and completing any agreed upon Phase IV clinical studies. Maintaining vigilance during post-marketing surveillance is important to discover new safety risks and provide additional information on a drug's benefits and risks.
This document summarizes the key lessons learned from food security policy advisory projects in Cambodia, Ethiopia, and Mozambique. The projects aimed to better integrate food and nutrition security into national development policies, strategies, and programs. They found that while the projects raised awareness and established coordination mechanisms, fully integrating food security required engagement across many sectors. Linking policy work with pilot programs helped demonstrate solutions and engage stakeholders. Ensuring political will, strong institutions, local capacity, and continued donor support will be important for sustainability. Overall, the projects highlighted the cross-cutting nature of food security and the need for a coordinated, multisectoral approach to policy integration.
Este documento apresenta a Estratégia de Segurança Alimentar e Nutricional de Moçambique para 2008-2015 (ESAN II), que revê e atualiza a estratégia anterior de 1998. A ESAN II incorpora uma abordagem baseada nos direitos humanos, reconhecendo o direito humano à alimentação adequada. O documento faz um diagnóstico da situação atual de segurança alimentar no país e estabelece objetivos e pilares estratégicos para melhorar o acesso a alimentos nutritivos, reduzir a desnutrição
The document discusses ICH Q7 guidelines for good manufacturing practices for active pharmaceutical ingredients. ICH Q7 provides guidance on GMP for manufacturing APIs to ensure quality, safety and efficacy. It covers requirements for facilities, equipment, documentation, materials management, production, packaging, labeling, testing, validation, and quality management. Adhering to ICH Q7 helps ensure consistent API quality and reduces batch variations.
ICH 7- GMP Guidance for API-questions & answersMD. SELIM REZA
This document provides clarification on uncertainties regarding the interpretation of certain sections of the ICH Q7 guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients. It answers questions on applying GMP to manufacturing steps before and after the defined API starting material. It also addresses questions on applying GMP to steps that add substances to stabilize an API, and clarifies that ICH Q7 should be applied to mixtures classified as an API.
Our leading-edge manufacturing facilities located in Southern California allow PYRAMID to offer the pharmaceutical and biotech industries a wide range of services including aseptic vial and syringe filling, as well as lyophilization capabilities, for both Clinical and Commercial products.
Vskills certification for Biopharmaceutical Professional assesses the candidate as per the company’s need for developing and managing biopharmaceuticals. The certification tests the candidates on various areas in types, sources of biopharmaceuticals which also includes methods of production and legal issues.
http://www.vskills.in/certification/Health-Nutrition-and-Well-being/Certified-Biopharmaceutical-Professional
This presentation discusses the revision of the FDA's Question-based Review (QbR) system for generic drug submissions. The QbR questions were revised to fully incorporate quality-by-design (QbD) elements like quality target product profiles and critical quality attributes. Key changes include removing questions answered with 'refer to DMF' and revising 'yes/no' questions. The revised QbR aims to facilitate a more science- and risk-based review of generic drug applications and further encourage QbD principles. A mock application and FAQ are in development to aid understanding of the new QbR. Feedback on the revised questions is welcome.
This document discusses ICH Q7 and Q11 guidelines for good manufacturing practices for active pharmaceutical ingredients. It defines key terms like starting material and active pharmaceutical ingredient. It also discusses characteristics that must be evaluated for active pharmaceutical ingredients like elucidation of structure, impurities, specifications and analytical validation. The document contrasts traditional and enhanced approaches to development and manufacturing under ICH Q11, noting the traditional approach relies on set points, operating ranges and release based on meeting criteria, while the enhanced approach uses greater science and risk knowledge to identify critical quality attributes and develop a control strategy.
This document discusses Good Manufacturing Practices (GMP) for pharmaceutical products as outlined by the World Health Organization (WHO). It provides definitions and explanations of key GMP concepts including quality assurance, quality management, and ensuring consistent production of pharmaceuticals according to appropriate quality standards. It also discusses WHO involvement in establishing GMP guidelines and differences between GMP and current Good Manufacturing Practice (cGMP). The document outlines basic GMP principles for quality management, sanitation, qualification and validation, complaints and recalls, and more. It emphasizes that quality failures can result in regulatory warnings, market withdrawals, supply disruptions, and loss of credibility with patients and regulators.
The document summarizes the BRC Global Standard for Storage and Distribution. It was introduced in 2006 and last updated in 2010 to complement other BRC global standards. The primary objective is to maintain food safety and quality as products move through the supply chain. The standard aims to complete the chain between manufacturers and retailers. Audits last 1.5 days on average and assess non-conformities, with corrective actions required to achieve certification. Requirements address issues like hazard analysis, quality management, facilities, vehicles, operations, and training.
Pharmaceutical Industry Departments roles and responsibilities manasa life sc...ManasaLifeSciencesMa
Pharmaceutical Industry Departments and its roles and responsibilities were discussed. Product selection, Development, Manufacturing, Product approval, Marketing
Stabicon Life Sciences is a contract research organization located in Bangalore, India. It was established in 2010 and is approved by regulatory agencies in India, Canada, and the US. The company offers formulation development, analytical testing, stability studies, and other CRO services. It has a dedicated cGMP and cGLP compliant laboratory with experienced professionals and facilities for method development, validation, microbiology testing, and more. Stabicon aims to deliver high quality services to pharmaceutical clients at competitive costs while maintaining confidentiality and assisting throughout product development and registration.
Introduction of training on pharmaceutical quality system Dr.Milind Pathak
The document provides information about a training on pharmaceutical quality systems organized by Quality Circle Forum of India (QCFI). QCFI is a non-profit organization that provides training to professionals at different levels in industries. The Ankleshwar chapter of QCFI has launched activities like 6-month evening coaching and campus training programs on pharmaceutical quality systems and regulatory guidelines for pharmaceutical industries. The training modules will cover topics like cGMP, documentation, sanitation, validations, quality risk management and ICH guidelines. The training will be participatory in nature followed by an evaluation test, and certificates will be distributed. It will be conducted by Dr. Milind Pathak, who has 29 years of experience in quality assurance, quality systems and
The document discusses ICH Q7, a guideline for good manufacturing practices for active pharmaceutical ingredients. It aims to improve quality, enhance productivity and effectiveness of API manufacturing. ICH Q7 applies to APIs made through chemical synthesis, extraction, fermentation or combinations and establishes requirements for quality management, personnel, facilities, equipment, documentation, materials management, production controls, packaging and more. Adherence to ICH Q7 helps ensure APIs are safe, effective and of good quality and prepared according to cGMP standards expected by regulatory agencies like the FDA.
Good Manufacturing Practice (GMP) 2day course Jo Havemann
The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions
Industry Program In Pharma Quality Assurance And Quality Controlbiinoida
The document describes an industry program in pharmaceutical quality assurance and quality control offered through distance learning. The 12-month program aims to enhance knowledge of quality professionals and provide in-depth training in areas like GMP, quality assurance, regulation, and statistics. Participants can pursue careers in quality assurance, control, engineering, and management and work for major pharmaceutical companies upon completion.
New PDA/IPEC Technical Report on Excipient Risk Assessment - insights for dru...MilliporeSigma
Access the interactive recording: https://bit.ly/37HqbTK
Abstract:
Since March 2016 the EU Guideline to ascertain the appropriate GMP for pharmaceutical excipients is legally binding. Although the EU Guideline itself provides a high level description how to perform the risk assessment, the implementation can be challenging. In January 2018 PDA and IPEC formed a joint Task Force with the objective to develop a joint Technical Report to share best practices with industry. This Technical Report was published in December 2019. In this webinar you will be introduced to the new Technical Report, its objective, proposed approaches and examples shared by PDA/IPEC member companies.
This document provides an introduction and overview of a training session on Good Manufacturing Practices (GMP) for the 21st century. It notes that the presentation will reflect the presenter's views and is not meant to represent any official policies. Examples of recent drug contamination and mix-ups are presented to illustrate the importance of GMP in ensuring consistent quality, preventing contamination and mix-ups. GMP is described as a set of regulatory methods to inspect manufacturing practices to protect the integrity and quality of products intended for human use and ensure they are consistently produced and controlled.
Tackling the challenges of single-use manufacturing for ADCsMilliporeSigma
Watch the full webinar here: https://bit.ly/2Ix3uud
In this webinar, you will learn:
• How SU assemblies are used in the ADC development space
• Recommendations for consistent transfer of SU processes to manufacturing
• Understand if SU technology is right for your product
• Evaluate the pros and cons of SU for ADCs
Antibody Drug Conjugates (ADCs) are a class of biomolecules that has seen rapid growth with multiple new commercial products in 2020. Adoption of SU systems has been slow due to concerns for safe handling of organic solvents and the toxic small molecule payload. Recent advances in Single-use technology have overcome these concerns and now provide understanding of the suitability, scalability, and fluid compatibility of both the single-use components as well as the supporting hardware and controls. In this webinar, we show how the single-use technology can deliver consistent and scalable ADC chemistry and functionality with desired final product specifications and high yield.
This document provides an overview of post-marketing surveillance requirements for drug products. It discusses general reporting requirements including field alert reports, annual reports, labeling changes, and adverse event reporting. The key aspects of post-marketing surveillance are monitoring adverse drug reactions, ensuring compliance with manufacturing standards, and completing any agreed upon Phase IV clinical studies. Maintaining vigilance during post-marketing surveillance is important to discover new safety risks and provide additional information on a drug's benefits and risks.
This document summarizes the key lessons learned from food security policy advisory projects in Cambodia, Ethiopia, and Mozambique. The projects aimed to better integrate food and nutrition security into national development policies, strategies, and programs. They found that while the projects raised awareness and established coordination mechanisms, fully integrating food security required engagement across many sectors. Linking policy work with pilot programs helped demonstrate solutions and engage stakeholders. Ensuring political will, strong institutions, local capacity, and continued donor support will be important for sustainability. Overall, the projects highlighted the cross-cutting nature of food security and the need for a coordinated, multisectoral approach to policy integration.
Este documento apresenta a Estratégia de Segurança Alimentar e Nutricional de Moçambique para 2008-2015 (ESAN II), que revê e atualiza a estratégia anterior de 1998. A ESAN II incorpora uma abordagem baseada nos direitos humanos, reconhecendo o direito humano à alimentação adequada. O documento faz um diagnóstico da situação atual de segurança alimentar no país e estabelece objetivos e pilares estratégicos para melhorar o acesso a alimentos nutritivos, reduzir a desnutrição
This document is the interim final version 4.0 of the GLOBALG.A.P checklist for integrated farm assurance for fruit and vegetables. It provides guidance for producers on meeting standards for soil management, substrates, pre-harvest activities such as water quality and fertilizer application, harvesting, and related food safety requirements. The checklist includes over 50 control points producers must meet for certification and is intended to be valid from January 2011 onward.
The document provides guidelines for organizing workshops to jointly plan actions to address malnutrition through an integrated multi-sectoral approach. It describes how to use problem and solution tree analyses to clarify objectives, organize planning workshops, and adapt the methodology for different contexts and purposes such as training, partnership development, and surveillance system design. The workshops bring together stakeholders from different sectors to develop a shared understanding of the local causes of malnutrition and identify opportunities for strengthening linkages and synergies between existing interventions.
Improving child nutrition offers one of the highest returns on investment of any development program, with potential returns as high as 39 to 1. Investing in infant and young child nutrition can save over 1 million lives each year, benefit 360 million children and mothers, and increase a country's GDP by 2-3%. A well-nourished child is more likely to continue their education, have a higher IQ, and earn up to 46% more over their lifetime. Solutions like preventing and treating malnutrition, promoting breastfeeding and healthy foods, and increasing micronutrients through fortification can shape a child's future during the critical first 1,000 days from pregnancy to age two.
Fsnau micronutrients-in-somalia-flipchart-english[1]Katia Santos Dias
The document discusses the results of a study on the impact of COVID-19 lockdowns on air pollution. Researchers found that lockdowns led to significant short-term reductions in nitrogen dioxide and fine particulate matter pollution globally as transportation and industrial activities declined substantially. However, the document notes that continued long-term progress on air quality will require systemic changes rather than temporary reductions from emergency measures.
2.6 a addressing-micronutrient_deficiencies_omar_daryKatia Santos Dias
This presentation discusses strategies to address nutritional deficiencies through food fortification and home fortification in Guatemala. It notes that stunting rates in Guatemala remain high despite programs addressing protein-energy malnutrition. The presentation explores causes of stunting beyond undernutrition, including breastfeeding practices and stimulus. It advocates combining food vehicles like wheat flour, rice, and maize flour to fortify more nutrients and reach more people. The presentation also discusses using micronutrient powders and lipid-based supplements as "in-home fortification" strategies to improve children's nutrition. It emphasizes the need for integrated, population-level solutions that are tailored to local contexts.
GFSI was launched in 2000 by major food retailers and manufacturers to improve food safety standards globally. GFSI sets benchmarking requirements for food safety management systems and recognizes compliant standards. Over 30,000 companies worldwide are certified to GFSI standards, which improves food safety, consumer protection, and supply chain management. GFSI certification provides benefits like reduced risk of outbreaks and improved efficiency, while driving innovation and collaboration across the food industry.
Today’s food supply chain presents complex challenges, and many of the world’s largest food retailers are mandating supplier certification to Global Food Safety Initiative (GFSI) schemes.
In this webinar SAI Global's Food Safety Consultant Dr Bob Strong gives an overview The webinar will provide you with an overview of GFSI schemes, their key differences, how to select the right standard for your organization, and tips on becoming certified.
Global Trends in Accreditation & CertificationSQF Institute
Global trends in accreditation and certification include:
1) Increased focus on social responsibility and environmental responsibility standards in addition to traditional management system standards. Scheme owners are adding modules to address issues like social and ethical sourcing.
2) A push for greater harmonization and recognition of private food safety standards at a global level through organizations like GFSI benchmarking schemes.
3) Consolidation of audits where certifying bodies can audit multiple standards during a single audit to reduce costs and duplication for suppliers certified to multiple standards.
Food safety standards and certificationsNaim Khalid
This document provides information on various food safety standards and certifications. It discusses the differences between food safety and safe food. It also explains the Global Food Safety Initiative (GFSI) which aims to ensure safe food through continuous improvement in food safety management systems. Several certification programs are described, including Safe Quality Food (SQF), British Retail Consortium (BRC), International Food Safety (IFS), ISO 22000, Hazard Analysis and Critical Control Points (HACCP), and Global GAP. The benefits of these certifications for food producers are to assure customers of safe food and access to major retailers through demonstrating strong food safety practices.
HACCP and ISO 22000 are food safety systems. HACCP identifies potential food safety hazards and aims to control risks. It uses a seven-principle approach including hazard analysis and identification of critical control points. ISO 22000 provides requirements for a food safety management system and benefits various stakeholders by helping ensure a safe food supply chain and reducing foodborne illness and hazards. Both systems aim to protect consumer health and facilitate fair food trade practices internationally.
HACCP (Hazard Analysis and Critical Control Points) is a systematic preventative approach to food safety that identifies potential food safety hazards, finds ways of preventing them, and establishes procedures to reduce risks to safe levels. It involves identifying potential hazards at specific points in the food production process, establishing controls to prevent hazards, and monitoring these control points to ensure effectiveness and safety of the food. The Codex Alimentarius Commission establishes international food standards, guidelines and codes of practice to protect consumer health and ensure fair practices. HACCP was developed in the 1960s and has since been recognized internationally as an effective tool for modern, science-based food safety systems.
From QMS to FSMS: Intersecting Compliance, Audit-Readiness, and ProductionSafetyChain Software
This document provides an overview of a webinar on intersecting quality management systems (QMS) and food safety management systems (FSMS). It discusses how QMS and FSMS have evolved from standards like ISO 9000 and ISO 22000. Key aspects covered include hazard analysis, prerequisite programs, HACCP, and how integrating QMS and FSMS can improve efficiency. The webinar speaker, Ranjeet Klair, has over 20 years of experience in food safety and will discuss best practices for compliance and audit-readiness.
Yves Rey, former chairman of the GFSI Board and corporate quality general manager at Danone, discusses the vision and objectives of the Global Food Safety Initiative (GFSI). The GFSI aims to ensure safe food for consumers everywhere through continuous improvement in global food systems. It works to reduce food safety risks throughout the food chain, manage costs in the supply chain, develop competencies and capacity building, and enable a platform for knowledge exchange. A key objective is establishing equivalence between food safety schemes through benchmarking against GFSI requirements. This enhances trade opportunities and reduces costs. The GFSI also implements integrity programs around training, auditing competences, and private-public partnerships. In China specifically, it seeks to increase recognition of third
ISO, ISO 22000. ISO 14000, ISO 9000, Differentiate between ISO 22000 and HACCP, Prerequisite programs, Critical points, ISO, HOW to get ISO certification,
ISO 22000 is an international standard for food safety management systems. It benefits various stakeholders in the food industry. For businesses, it provides a basis for developing products and services that meet widespread acceptance. For consumers, it provides assurance of quality, safety, and reliability of food products. For governments, ISO 22000 provides technological know-how and a basis for health and safety legislation. Overall, ISO 22000 aims to ensure safe food and reduce foodborne diseases through better quality control and documentation throughout the entire food supply chain.
FSSC 22000 Certification Key Elements Requirements and Benefits.docxOFFICE
The Foundation Food Safety System Certification 22000 (FSSC 22000) offers a complete certification Scheme for the auditing and certification of Food Safety Management Systems (FSMS) or FSMS and Quality Management Systems (FSSC 22000-Quality).
ISO 22000 provides benefits to various stakeholders in the food industry. It establishes consensus agreements between suppliers, users, regulators and other groups to ensure food safety. ISO 22000 certification allows businesses to expand globally and provides consumers assurance regarding quality, safety and reliability. The standard also benefits governments by providing technical knowledge, a basis for legislation, and economic and social advantages like trade liberalization and food security. Overall, ISO 22000 helps minimize food safety hazards across the entire food supply chain.
As food safety continues to be a worldwide public health issue, the need for improved and more effective food safety systems has increased over the past three decades. A combination of national and international standards, industry needs, customer demands and many other factors has led to tremendous improvements of Food Safety Management Systems.
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GFSI management systems establish standards for food safety management that are recognized globally. Regulations in both the US and EU have increased requirements for HACCP food safety plans. GFSI aims to benchmark food safety schemes, improve supply chain food safety, and strengthen consumer confidence. Major retailers increasingly require suppliers be certified under a GFSI-recognized standards like ISO 22000 and SQF. Implementing a comprehensive food safety management system with HACCP, prerequisite programs and integrated processes can help companies meet regulatory and customer requirements.
GFSI Management Systems- What They Mean For Your Operations and Your BusinessNorthwest Analytics
Jeffery Cawley, Northwest Analytics, discusses the Global Food Safety Initiative (GFSI) and the requirements for a compliant Food Safety Management System (FSMS) to meet GFSI standards.
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Presentation on ISO 22000 food safety management system, an international standard. It helps give to ISO 22000 training to teach food safety requirements, steps for FSMS implementation as well as food safety system advantages to the performance of organization.
Globalization and cross-national trade of food products have increased the number of foodborne illness in
many countries. Outbreaks of botulism, salmonellosis and listeriosis are considered to be the largest food
poisoning outbreaks which cause millions of illnesses, thousands of hospitalizations, and many deaths
every year.
1. COMPARING GLOBAL FOOD SAFETY INITIATIVE
(GFSI) RECOGNISED STANDARDS
A DISCUSSION ABOUT THE SIMILARITIES AND DIFFERENCES BETWEEN THE REQUIREMENTS OF
THE GFSI BENCHMARKED FOOD SAFETY STANDARDS
APRIL 2011
AUTHORS
Supreeya Sansawat
Global Food Business Manager, SGS
Victor Muliyil
Technical Manager for North America Food Safety Services, SGS
2. ABSTRACT
This document aims to provide an and the GLOBALG.A.P. For each of a customised single food audit. This
overview of the Global Food Safety these, the requirements, benefits and could be of benefit because food safety
Initiative (GFSI) and what it means for certification processes are reviewed. standards have an extensive cross-over
an international food safety standard There are five further schemes that with environmental, health & safety
to be GFSI approved. It then goes on are covered in brief. The most generic and quality standards. A further issue
to discuss each of the GFSI approved of the schemes and those most is that there is not necessarily one
schemes individually looking in detail commonly adopted by branded goods ‘optimal fit’ food safety standard for
at the key schemes which are offered manufacturers (FSSC 22000, BRC, SQF any given organisation. This means
by the Global Food Standard (BRC), 2000 and IFS) are then compared, by that a combination of schemes brought
FSSC 22000, the International Features discussing the criteria, similarities and together in one audit procedure may be
Standard Food (IFS Food), the Safe differences between the schemes. a more suitable solution.
Quality Food SQF 2000 and 1000 The paper then looks at the merits of
CONTENTS
I. EXECUTIVE SUMMARY 2
II. THE GLOBAL FOOD SAFETY INITIATIVE 3
III. GFSI RECOGNISED FOOD SAFETY SCHEMES 5
IV. A COMPARISON ON THE GFSI RECOGNISED SCHEMES 16
V. COMBINING GFSI RECOGNISED SCHEMES WITH THOSE RELATED TO
THE ENVIRONMENT, HEALTH & SAFETY AND QUALITY 24
VI. CONCLUSION 25
1
3. I. EXECUTIVE SUMMARY
Retailers, manufacturers, foodservice they were purchasing and eating was as more and more organisations within
operators, caterers, industry guaranteed as safe for consumption, the the industry are expecting entire
associations, technical experts and unneccesarily repetitive audits needed supply chains for a given product to
governments all have one thing in to be reduced. It was also important prove this capability. Organisations
common when it comes to food safety. that, as food supply chains stretch audited and certified through a GFSI
They recognise that consumers’ across the globe, any industry solution approved scheme increase their
confidence dropped to an all time low covers both the end-to-end supply chain chances of being a chosen supplier to
after a number of public food scares and is able to influence the industry on retailers and/or manufacturers who
sent shock waves through the industry an international scale. As a result of all demand their suppliers hold a GFSI
just over ten years ago. As with many these combined issues, the Global Food approved certification. The vision of
industries, this widespread concern Safety Initiative (GFSI) was developed. the GFSI benchmark of ‘once certified,
for safety prompted action. Retailers/ All interested parties around the world accepted everywhere’, is moving in
branded manufacturers began to audit joined forces to support the creation of the direction of being realised, both
their suppliers so that they could feel a benchmarking and approval scheme across the industry and across the
confident in their suppliers’ abilities to that would lay the foundations for an world. With a number of international
meet their food safety system demands. industry-wide expectation in terms GFSI approved food safety standards
This meant that suppliers often found of food safety management system now available competitive suppliers are
themselves being repeatedly audited by deliverables. This then became the already certificated, seeking certification
individual customers, creating a massive benchmark against which all food safety or developing their processes and
duplication of audit procedures. standards can be tested, verifying identifying the best certification scheme
The industry soon came together to that the standard once gained by an for their organisation. The hope is that
look at what could be done to improve organisation, proves they are producing as this becomes even more widespread,
the situation and reduce the strain or handling food at the level of consumer confidence can be fully
on suppliers while maintaining the safety specified. restored and food scares can become a
required safety levels. While consumers Holding a GFSI approved certification thing of the past.
needed a reassurance that the food is fast becoming an industry standard
2
4. II. THE GLOBAL FOOD SAFETY
INITIATIVE (GFSI)
The Global Food Safety Initiative (GFSI) As a result of this continued duplication CEOs and senior management from
was originally set-up as a result of food of audits, the GFSI set out to develop 650 retailers, manufacturers, service
safety scares in early 2000. Its primary a uniform structure for food safety providers and other stakeholders across
purpose is to ensure the safety of food standards. It did this by detailing the food industry. Covering all areas in
reaching all consumers internationally, food safety criteria that should be terms of both products and international
but it also aims to develop efficiencies, incorporated and by putting common locations the Forum is considered to be
promote transparency, guide cost procedures in place for accreditation truly representative of the needs of the
savings and become a platform for and certification bodies verifying the industry as a whole.
continous improvement in the area implementation of standards. Under the guidance of the Forum,
of food safety. It does this by leading It is important to note that GFSI is the GFSI is then governed by: a
the global food industry towards a the standard for benchmarking not Board; Technical Working Groups
harmonised approach to food safety the standard for auditing, There are and; a Stakeholder Group. While the
management systems. a number of food standards have Board sets the strategic direction and
Before the GFSI was established, been submitted for benchmarking oversees the GFSI on a daily basis
retailers and major buyers across the and that ensure it meets a minimum the Technical Working Groups provide
food industry demanded specific food requirements of GFSI guideline. technical expertise and advice. The
safety requirements for particular Through this approach the GFSI aims Technical Groups combine to form a
products. To prove that these to deliver on its mission to: “Provide Technical Committee composed of
requirements were met, food suppliers continuous improvement in food retailers, manufacturers, food service
often had to have a number of different safety management systems to ensure operators, standard owners, certification
audits of their premises and systems, a confidence in the delivery of safe food bodies, accreditation bodies, industry
process that cost them time and money. to consumers worldwide”. In order to associations and other technical experts.
From audit to audit there was also do this effectively, it operates with four The GFSI Stakeholder Group brings
considerable duplication. major objectives in mind. These are to: retailers, manufacturers, certification
This issue was dealt with, to some bodies, accreditation bodies, standards
1. Reduce food safety risks by owners, food safety experts and
extent, by the industry developed delivering equivalence and
national and regional schemes, such consultants together in a forum to
convergence between effective food discuss issues related to the GFSI.
as the BRC or the IFS Food standards. safety management systems
While these did aggregate the needs All these interested parties have worked
and demands of some buyers, there 2. Manage cost in the global food together to develop the GFSI Guidance
were many circumstances where system by eliminating Document. This multi-stakeholder
suppliers continued to be audited redundancy and improving document sets out the requirements
through numerous processes. operational efficiency for food safety management schemes
3. Develop competencies and and provides a framework against which
capacity building in food safety to these schemes can be benchmarked. It
create consistent and effective global brings together three key elements of
food systems food production:
4. Provide a unique international • Food Safety Management Systems
stakeholder platform for • Good Practices and HACCP
collaboration, knowledge exchange Requirements (GAP, GMP, GDP)
and networking
• Requirements for the delivery of food
The GFSI is run by the Consumer safety management systems
Goods Forum, which brings together
3
5. ELEMENTS OF ALL GFSI RECOGNISED SCHEMES
Best
Practice
GFSI Recognized Schemes
ISO Standard: ISO22000
Legislation - Food Law
Codex - HACCP Principles - GMP
Source: GFSI: Enhancing Food Safety Through Third Party Certifcation
In June 2007 the GFSI achieved Carrefour, Tesco, Metro, Migros, Ahold, manufacturers have agreed to recognise
a major breakthrough, which has Wal-Mart and Delhaize pathed the way the GFSI benchmarked schemes. These
since augmented its beneficial role in for the future growth in acceptance of include: Asda; ConAgra Foods, Coop;
international food safety. At that time GFSI approved schemes and with that Campbells; Cargill; ICA, Kroger;
seven major food retailers all agreed to started the GFSI off in the direction of Sodexo; and The Coca Cola Company,
reduce duplication in the supply chain achieving its vision of ‘once certified, among others.
through the common acceptance of any accepted everywhere’. Subsequently,
of the GFSI benchmarked schemes. many further food retailers and
4
6. III. GFSI RECOGNISED FOOD
SAFETY SCHEMES
There is currently a range of The BRC Global Food Standard • Site Standards
manufacturing schemes, primary was developed with the objective – External Standards
production schemes and combined of specifying the safety, quality
schemes that have been benchmarked and operational criteria required for – Security
and approved by the GFSI. Each varies in food manufacturers to comply with – Internal Site Standards
terms of the scope and criteria covered regulations and protect consumers. It – Utilities
as well as in structure, the certification requires all companies involved in the
process, validity and the reporting and end-to-end supply chain have a clear – Equipment
management conducted. understanding of the products they – Maintenance
Each standard has a different structure produce and distribute and have the – Staff Facilities
and procedures for meeting each of systems in place to identify and control
food safety hazards. – Chemical & Physical Product
the three main areas of requirements: Contamination Control
The food safety management system;
Good manufacturing practices, good The Requirements – Housekeeping & Hygiene
distribution practices and Standard are as follows: – Waste/Waste Disposal
good agraicultural practices; and – Pest Control
• Senior Management Commitment and
Hazard analysis and the critical control
Continuous Improvement – Storage & Transport
point (HACCP).
• Food Safety & Quality • Product Control
Here we take a look at each of the
Management System
schemes individually: – Product Design/Development
– Food Safety & Quality Policy
– Handling Requirements for
MANUFACTURING SCHEMES – Food Safety & Quality Manual Specific Materials – Materials
– Organisational Structure, Containing Allergens and Identity
Global Food Standard (BRC) Responsibilities and Preserved Materials
The BRC (British Retail Consortium) Management Authority – Foreign Body Detection
is the leading trade body for UK – Contract Review & Customer Focus – Product Packaging
retailers. Whether a retailer is a large
– Internal Audit – Product Inspection and Laboratory
multiple or department store, or a small
– Purchasing – Supplier Approval & Testing
independent shop, the BRC protects
their interests. The BRC has developed Performance Monitoring – Control of Non-conforming Product
a set of Global Standards, which is an – General Documentation – Product Release
international product safety and quality Requirements
• Process Control
certification programme and suppliers
– Corrective & Preventative Action
in more than 100 countries are currently – Control of Operations
certified against it. Retailers and – Traceability
– Quantity – Weight Volume &
manufacturers around the world use the – Complaint Handling Number Control
BRC standards as their chosen approved
– Management of Incidents, Product – Calibration & Control of Measuring
standards for suppliers. The BRC covers
Withdrawal and Product Recall and Monitoring Devices
the supply chain with four related
standards: BRC Global Food Standard; • Personnel
BRC Storage and Distribution; – Training
BRC IOP for Food Packaging and; BRC
– Access & Movement of Personnel
Consumer Products.
– Personal Hygiene
– Medical Screening
– Protective Clothing
5
7. The Benefits The Certification Process on-site visit within 28 calendar days
of the audit. Once non-conformities
There are a number of benefits for The BRC certification process consists
have been addressed and the auditor
manufacturers who are certified against of four steps:
has accepted the evidence, an
the BRC Standard. A number of these • Step A – Manufacturers are provided independent technical review of the
benefits apply across other standards with a proposal based on the size audit is conducted by an authorised
while some are specific to the BRC and nature of their organisation. They Certification Manager who approves
Global Standard for Food Safety, can then proceed with the audit by the issuance of a certificate.
these are: accepting the proposal from the
• Step D – Full recertification audits
• The BRC standard has descriptive certification body.
are scheduled at defined intervals
requirements for process and hygienic • Step B – There is then an optional depending on the outcome of the
control which provide clear guidelines ‘pre-audit’ stage, which is often useful certification audit. For Grade A and
as to how food safety should be in identifying any weaknesses in B audits this is 12 months later, for a
addressed systems and in building confidence Grade C audit this is 6 months later.
• It has a simple certification process before the formal audit. The audit is a full re-audit conducted
which only requires an on-site audit, • Step C – The formal audit is an on-site in the same way as the initial audit,
there is no requirement for a desk audit. All parts of the site and process but the implementation of the action
study step covered in the scope are assessed plan is also reviewed, addressing past
• It includes a voluntary recertification to determine compliance with every non-conformities and whether the
audit, allowing an organisation clause of the standard. Manufacturers audit has taken place by the re-audit
to demonstrate its high level of receive a Corrective Action Report at due date.
commitment as the certification body the end of the formal audit, identifying
can be asked to re-audit the facilities any observed non-conformities.
at anytime Depending on their nature, these non-
• The standard has a focus on quality, conformities should be closed with
as well as food safety and legality documentary evidence or through an
BRC CERTIFICATION PROCESS
Year 1
STEP C
STEP A Close out all non Issue Certificate STEP D
Onsite conformances after successful
Agree
Certification audit Recertification
Contract (if any)
Audit
STEP B
Optional
Pre-Audit
6
8. Food Safety System Certification reviewed against the PAS 220 and the • Applicable codes of practice related to
FSSC 22000 additional requirements to ensure they food safety, customer requirements
receive the GFSI approved certification. related to food safety, any other
Owned by The Foundation for Food
The FSSC 22000 can be applied to additional requirements on food safety
Safety Certification, the FSSC 22000
a wide range of food manufacturing determined by the organisation
(also known as FS 22000) combines the
ISO 22000 Food Safety Management organisations, irrelevant of their – The food safety system shall ensure
Standard with the Publicly Available size or the complexity of their food and demonstrate conformity with
Specification (PAS) 220 (or ISO/ management processes. This includes these requirements
TS 22002-1) along with some other public and private companies, and those – Specification of services
requirements. Alone the ISO 22000 that manufacture perishable animal or
vegetable products, products with a • The food manufacturing organisation
was not sufficient to achieve GFSI
long shelf life, food ingredients and/or shall ensure that all services
approval due to the weaknesses in the
food additives. (including utilities, transport and
prerequisite program (PRP) content. As
maintenance) which may have an
a result a group of large multinational
impact on food safety:
companies came together to write the The Requirements
PAS 220, which focuses on covering • Have specified requirements
The FSSC 22000 requires that each of
the necessary Prerequisite programs • Are described in documents to the
the following are met:
for food manufacturing. However, the extent needed to conduct hazard
GFSI required that there was an overall • Food Safety Management System
analysis
industry owned scheme that brought the ISO 22000
• Are managed in conformance with
two individual programs together, with • Prerequisite Programmes PAS 220 or
the requirements of BSI-PAS 220,
an emphasis on regulatory and customer ISO/TS 22002-1
clause 9
requirements. So with this in mind,
• Additional Requirements
the FSSC 22000 was developed. This • Supervision of food safety
(3 additional requirements)
combination in the form of the FSSC personnel in relation to applicable
22000 created a standard that is fully • Inventory of Applicable Regulations food safety principles
recognised by the GFSI and serves as an • The food manufacturing organisation • The organisation shall ensure the
international benchmark for food safety. must have an inventory of: effective supervision of the personnel
Designed for food manufacturers • Applicable foreign, regulatory and in the correct application of the
who supply their products to major statutory requirements on food safety, food safety principles and practices
food retailers, or plan to do so, any including those applicable to: Raw commensurate with their activity
manufacturer already certified against materials/services provided, and
the ISO 22000 only needs to be products manufactured and delivered
7
9. The Benefits Further to this, another major benefit of examination. A report then identifies
the FSSC 22000 is its acceptance by the any concerns or observed non-
Most of the major benefits of the FSSC
European Cooperation for Accreditation compliances so that immediate action
22000 relate to its comprehensiveness
(EA). This accreditation, which was can be taken as required.
as a food safety management system
awarded in October 2010, means that • Step D – This is ‘Stage 2’ of the initial
standard. This is because:
most accreditation bodies will now audit process. The audit includes
• It provides a good framework against accept FSSC 22000. interviews with employees and
which an organisation can develop
examination of records. Observation
its food safety management system;
The Certification Process of working practices determines
it is not too descriptive and has the
The FSSC 22000 certification processes how compliant actual processes
flexibilty to allow the organisation to
is identical to that for the ISO 22000 and are with the standard and with an
choose the best way to control its
consists of six steps: organisation’s own documentation
own system and ensure food safety
system. At the end of this stage, the
policy and objectives are being met • Step A – A proposal from the
findings of the audit are presented
• It includes comprehensive certification body is provided based on
along with other observations and
requirements detailing how the the size and nature of an organisation.
opportunities for improvement. Once
organisation can conduct an effective Once this is accepted the audit
the non-conformities have been
HACCP studies and HACCP plan process can proceed.
addressed, a technical review of the
• The standard promotes continuous • Step B – There is then an optional audit will then be conducted by an
improvement in food safety ‘pre-audit’ stage, which is often useful authorised Certification Manager to
in identifying any weaknesses in confirm the issuance of a certificate.
• It targets its focus on food safety and
systems and in building confidence
legal compliance • Step E – Surveillance visits are
before the formal audit.
scheduled at either six or twelve
• It easily integrates with an
• Step C – The first part of the formal month intervals. During the visits, the
organisation’s existing management
audit is ‘Stage 1 – Readiness implementation of the action plan is
system or other systems in place,
Review’. This onsite audit evaluates reviewed, addressing the past non-
i.e. quality management systems,
the compliance of an organisation’s conformities and examining certain
environmental management
documented system with the mandatory and other selected parts
systems etc.
requirements of the standard. As part of the system in line with a provided
• It allows small, less structured of this the audit ensures correctness audit plan.
organisations to implement an and completeness of hazard
• Step F – Shortly before the third
externally developed system identification, CCP determination and
anniversary of the initial certification,
• Many major brands have adopted this that prerequisite programs are in place
a routine visit is extended to enable
system and standard so it is beneficial and appropriate to the business. After
a re-certification audit. Surveillance
for ingredients suppliers to be aligned this stage the rest of the audit can be
visits then continue, as before, on a
with these customers effectively planned and key elements
three-year cycle.
of the system can undergo an initial
FSSC 22000 & ISO 22000 CERTIFICATION PROCESSES
Assessment Year 1 Year 2 Year 3
STEP C Issue
STEP A Step D Certificate STEP E STEP F
Stage 1 after
Agree Stage 2 Visit Visit Visit Visit Visit Recertification
Certification successful
Contract Audit 2 3 4 5 6 Visit 1R
Audit audit
STEP B
Optional
Visit frequency notes:
Pre-Audit
Annual surveillance – 2 visits;
Twice-yearly surveillance – 5 visits
8
10. The International Features • HACCP System – Internal Audits
Standard (IFS) • Assemble HACCP Team – Site Factory Inspections
Originally developed by an association • HACCP Analysis – Process Control
of German retailers to serve as an
– Documentation Requirements – Calibration & Checking of Qualified
alternative to the BRC standard, French
– Record Keeping Measuring & Monitoring Devices
retailers and more recently Italian
retailers both play an important role in • Resource Management – Quantity Checking (Quantity
the specifics and operation of the IFS. Control/Filling Quantities)
– Human Resource Management
In parallel, all major retailers across – Product Analysis
Germany, France, Italy and many other – Human Resources
– Product Quarantine &
EU countries require their suppliers to • Personal Hygiene Product Release
comply with the IFS.
• Protective Clothing for Personnel – Management of Complaints from
The IFS aims to provide a uniform quality Contractors and Visitors Authorities & Customers
assurance and food safety standard for
• Procedures Applicable to Infectious – Management of Incidents, Product
retailer branded food products. Through
Diseases Withdrawal, Product Recall
a consistent evaluation system and
uniform audit procedures the standard – Training – Management of Non-conforming
generates transparency throughout the – Sanitary Facilities, Equipment for Products
supply chain, while ensuring regulatory Personal Hygiene and Staff Facilities – Corrective Actions
requirements are met and that retailers
• Production Process
and wholesalers are protected against
liabilities. – Contract Review The Benefits
The IFS provides a range of integrated – Product Specifications There are a number of benefits to IFS
checks on food safety and food quality certification, including:
– Product Development
in food processing companies. It • It has a simple certification process
– Purchasing
covers all product ranges, offering which only requires an on-site audit,
certification across the whole range of – Product Packaging there is no requirement for a desk
food processing with the exception of – Factory Environment Standards study step
agricultural primary production. The IFS
– Housekeeping & Hygiene • The standard has a focus on quality,
covers the complete food supply chain
as well as food safety and legality.
with three related standards: IFS Food; – Waste & Waste Disposal
Safety and Quality certification are
IFS Broker and; IFS Logistics. – Risk of Foreign Bodies, Metal, both covered in one audit saving
Broken Glass & Wood money by reducing the potential for
The Requirements – Pest Monitoring/Pest Control further audits
The audit assesses whether the – Receipt of Goods & Storage • Once certified, there is no need for
elements of an organisation’s quality a re-audit and certification for 1 year,
– Transport
management system are documented, this applies to all levels awarded
implemented, maintained and – Maintenance & Repair
• The IFS has a global network of
continuously approved. The elements – Equipment strategically placed offices covering
that are examined are as follows:
– Process Validation Europe, the Americas, and Asia
• Senior Management Responsibility supporting retailers, suppliers and
– Traceability (including GMOs and
– Corporate Policy Certification Bodies with operational,
allergens)
/Corporate Principles training and business development
– Genetically Modifidied Organisms
– Corporate Structure & Processes • Suppliers are given a 12-month time
(GMOs)
period to make corrective actions
– Customer Focus – Allergens, Specific Methods of (when not directly related to food
– Management Review Production & Treatment safety or regulatory compliance)
• Quality Management System • Measurements Analysis & allowing for budget planning and
Improvements continuous improvements
– HACCP
9
11. • Audits can be conducted electronically steps and excludes a desk study stage or observed non-conformities. An
with software support, which also in advance of the on-site audit: organisation is given two weeks to
provides reporting with year-on-year • Step A – A proposal is provided respond to the non-conformities (4
results, certification audit importing/ based on the size and nature of an weeks from audit date). These non-
analysis, and global category specific organisation. Once this is accepted conformities need to be closed with
benchmarking the audit process can proceed. documentary evidence or through
• All of the IFS criteria are risk-based an on-site visit. Once the non-
• Step B – There is then an optional conformities have been addressed
and there are no prescriptive elements ‘pre-audit’ stage, which is often useful and the auditor has accepted the
• The IFS Audit Portal is both a in identifying any weaknesses in evidence, an independent technical
database and a reporting and systems and in building confidence review of the audit is conducted by an
notification tool before the formal audit. authorised Certification Manager who
• The IFS offers an Integrity Program • Step C - The formal audit is an on-site approves the issuance of a certificate.
providing Quality Assurance and audit. All parts of the site and process • Step D – The certificate is valid for
a formal Complaint Management covered in the scope are assessed one year so a full recertification audit
system for retailer confidence to determine compliance with every is scheduled for twelve-months later.
clause of the standard. Organisations The audit is a full re-audit conducted
The Certification Process receive a Corrective Action Report at in the same way as the initial audit,
the end of this audit, identifying any but the implementation of the action
The IFS has two levels of certification:
observed non-conformities. Within plan is also reviewed and past
Foundation and; Higher Level. The
two weeks of this stage a pre-report non-conformities are addressed.
certification process consists of four
is issued identifying any concerns
IFS CERTIFICATION PROCESS
STEP C
STEP A Close out all non Issue Certificate STEP D
Onsite conformances after successful
Agree
Certification audit Recertification
Contract (if any)
Audit
Visit frequency notes:
STEP B Foundation Level – 12 Months
Optional Higher Level – 12 Months
Pre-Audit Follow up audit (if required) – No more than 6 months from
For IFS Logistics
Achieve higher level twice – 18 months.
10
12. Safe Quality Food (SQF) the Food Marketing Institute (FMI) in chain, suppliers can assure their
2000 Standard the USA, the scheme aims to meet customers that food has been produced,
the needs of buyers and suppliers processed, prepared and handled to the
The SQF 2000 standard is half of
worldwide. The standard certifies that highest possible standards at every step
a two-part scheme covering food
a supplier’s food safety and quality of the way.
manufacturing and distribution as well
management system complies with Each SQF standard can be achieved at 3
as primary production, the latter under
international and domestic food safety different levels( level 1 , level 2 and level
the SQF 1000 standard. Developed in
regulations. As the SQF standard 3.) level 2 being GFSI approved.
Western Australia but now owned by
incorporates the complete supply
THE THREE SQF CERTIFICATE LEVELS
• All requirements of the SQF2000 Code met
Compliant with
• SQF Certificate level 3 HACCP Quality
management
systems
• SQF 2000 Plan ++ (HACCP Plan)
Compliant
• SQF Certificate Level 2
with HACCP
food safety
requirements
• GMP/GHP ++
Compliant with
• SQF Expert systems based
• SQF Training on GMP
• SQF Certificate Level 1
The Requirements – Site Requirements and Approval • Enhancement of the organisation’s
– Food Handling Area food safety management system
The SQF 2000 standard requires each of
the following, where appropriate, to be – Water and Ice Supply • It demonstrates commitment to
achieved at the level detailed: producing and trading safe food
– Storage Facilities
• SQF 2000 System Requirements • It increases consumer confidence in
– Separation of Functions the products produced
– Commitment
– On-site Laboratories • Brand equity is enhanced
– Document Control and Records
– Staff Amenities • It prepares organisations for
– Specification and Product
– First Aid Facilities inspection by regulatory authorities
Development
– Waste disposal and other stakeholders
– Attaining Food Safety
– Exterior • It improves new market and
– Verification customer prospects
• Food Safety Fundamentals:
– Product Identification, Trace, • If SQF level 3 is achieved
Pre-requisite programs
Withdrawal and Recall organisations can use the SQF quality
– Site Security mark on their products
The Benefits
– Identity Preserved Foods
Certifying an organisation’s food
• Food Safety Fundamentals: management system against the SQF
Building and Equipment Design programme requirements brings the
and Construction following benefits:
11
13. The Certification Process against the requirements of the and opportunities for improvement
standard with the goal of achieving are presented to the organisation.
The SQF certification process consists
a better understanding of the nature Once non-conformities have been
of seven steps:
of the organisation, planning the addressed a technical review of the
• Step A – A proposal is provided rest of the audit as effectively as audit is conducted by an authorised
based on the size and nature of an possible and examining key elements Certification Manager to confirm the
organisation. Once this is accepted of the system at a basic level. After issuance of a certificate.
the audit process can proceed. this, organisations receive a report • Step F – Surveillance visits, if required,
• Step B – Once an organisation has identifying any concerns or observed are scheduled at six-month intervals
accepted the proposal, it registers on non-compliances so that immediate depending on the outcome of the
the SQFI website (www.sqfi.com). action can be taken as required. All certification audit and the grade
This is a requirement of the SQFI. major non-conformities need to be received. During the visits, we review
closed out prior to the Stage 2 audit. the implementation of the action plan
• Step C – There is then an optional
‘gap-analysis’ stage assessing an • Step E – This is ‘Stage 2 – addressing the past non-conformities
organisation’s readiness for the audit. Assessment Process: Certification and examining certain mandatory and
This is often useful in identifying Audit’ of the initial audit process. other selected parts of the system in
any weaknesses in systems and in The audit includes interviews line with an audit plan provided before
building confidence before the with employees and examination each visit.
formal audit. of records. Observation of an • Step G – Recertification audits are
organisation’s working practices scheduled at twelve-month intervals.
• Step D – The first part of the formal
determines how compliant its actual The Recertification audit is undertaken
audit is the ‘Stage 1 – Assessment
processes are with the standard and to verify the continued effectiveness
Process: Document Review’. Here
with its documentation system. At the of an organisation’s SQF System in
the compliance of an organisation’s
end of this stage, the findings of the its entirety.
documented system is evaluated
audit along with other observations
SQF CERTIFICATION PROCESS
Year 1
STEP D STEP E Issue STEP F
STEP A STEP B Certificate STEP G
Stage 1 Stage 2 after Surveillance
Agree Supplier SQF Onsite Annual
Document Onsite successful (depend on
Contract registration Recertification
review Certification audit grade)
STEP C
Optional
Pre-Audit
Best aquaculture practices Aquaculture Alliance is a non-profit NGO supply chain from hatchery and feed
(BAP) standards working to advance environmentally mill to farm and processing plant.
and socially responsible aquaculture Although individual BAP standards
The BAP Standards have been
and a safe supply of seafood. As part vary by facility type, each addresses
developed by the Global Aquaculture
of this, BAP certification covers the community and employee relations,
Alliance to address environmental
most important elements of responsible conservation of biodiversity, soil and
and social responsibility, animal
aquaculture and provides quantitive water management, and drug and
welfare, food safety and traceability
guidelines compliance can be measured chemical management.
in a voluntary certification program
against. The standards spread across
for aquaculture facilities. The Global
every type of organisation in the seafood
12
14. Global Red Meat Standard PRIMARY PRODUCTION SCHEMES seeds and all the farming activities up to
the point the product leaves the site. It
The Danish Agriculture & Food Council
CanadaGAP has become a key point of reference for
has, in co-operation with the Danish
Good Agricultural Practices. Fresh fruit
Co-operative of Slaughterhouses and The CanadaGAP Good Agricultural and vegetables, propagation material,
the Danish Meat Institute, developed Practices standard is owned by the integrated farm assurance (livestock,
the Global Red Meat Standard (GRMS). Candian Horticultural Council and is dairy, pigs, poultry, combinable crops
The scheme is specifically for the meat essentially an on farm food safety and grains, tea, coffee, aquaculture),
industry and aims to deliver EN45011 program. It combines national food flowers and ornamentals are all covered
certified standards though an auditing safety standards with a certification by the standard.
programme. The standard covers all system for the safe production,
aspects of transport, lairage, stunning, storage and packing of fresh fruits Members of GLOBALG.A.P are made up
slaughtering, deboning, cutting and and vegetables. of farmers, ranchers, product marketing
handling of meat and meat products and organisations, grower’s co-operatives,
The program is aimed at producers, food manufacturers and retailers.
assesses: Buildings; External Areas;
packers and storage intermediaries The standard and the certification are
Process Layout and Equipment; Product
of horticultural crops and has been approved by the Technical and Standards
Handling; Process Management and
designed to help them implement food Committees for each product sector:
Production Monitoring; Dispatch and
safety procedures into their operations. Crops; Livestock; and Aquaculture.
External Storage; Cleaning Programmes;
It is crop specific, laying out six differing These committees are supported by
Traceability; Product Recall Procedures;
sets of Good Agricultural Practices that FoodPLUS, which is the GLOBALG.A.P
Non-conformance Procedures; Product
have been developed by the horticultural secretariat based in Germany.
Specifications; Measuring Equipment;
industry and technically verified by
Complaints Procedures; HACCP
Canadian government officials. Each set
System; Internal Audit; Purchasing; The Requirements
of practices is based on the seven basic
Sales; Quality Management Systems;
principles of HACCP and is recognised The standards are separated into four
Management Responsibilities;
by the GFSI. different categories:
Personnel, Visitors and External Labour;
and Training. By achieving certification a primary • The GLOBALG.A.P Integrated Farm
producer can prove to their customers Assurance Standard (IFA)
Synergy 22000 that they have the systems and • The GLOBALG.A.P Compound Feed
procedures in place to minimise the Manufacturer Standard (CFM)
The Synergy 22000 certification risk of contamination to the product
combines two complementary • The GLOBALG.A.P Plant Propagation
produced. As part of this the auditor
standards to provide a GFSI recognised Material Standard (PPM)
gains evidence that an on-going,
Food Safety Management System. maintained food safety system is • The GLOBALG.A.P Risk Assessment
The initial standard is the ISO 22000, present within an organisation’s on Social Practice (GRASP)
which is a requirement for any operations. Within each, the requirements are
organisation within the food supply
organised into six sections, each of
chain, accompanied by either PRP
GLOBALG.A.P which having its own set of required
22000 or ISO TS 22002-1. Both these
GLOBALG.A.P promotes Good elements. Organisations being assessed
options cover Prerequisite Programme
Agricultural Practices (GAP) and as such against the standard combine the
(PRP) requirements for organisations in
is committed to supporting food safety applicable elements from each of the six
the food supply chain in relation to food
and sustainability in the agricultural, sections to make a package relevant to
safety management systems. As part
livestock and aquaculture supply their business. The six sections are
of the Synergy 22000 scheme and in
chains. Compliance with GLOBALG.A.P as follows:
conjunction with these standards, the
most appropriate PRPs need to be in standards ensures that food products • System rules referred to as
place, as specfied. The Synergy 22000 are safe and farmed or raised in a General Regulations (GR),
also sets out the operating procedures sustainable manner. This means the
• GLOBALG.A.P requirements referred
and protocol for the certification environmental impacts of farming
to as Control points and Compliance
scheme. The ISO 22000 and PRP 22000 operations are minimised, chemical
Criteria (CpCC)
combination is applicable to the entire inputs are reduced and that through
every aspect of the production process • Inspection documents referred to as
food chain and related activities, while
worker health and safety and animal Checklists (CL)
the combination of ISO 22000 & ISO TS
22002-1 is only applicable to the food welfare have been considered. • National GAP requirements referred
processing or manufacturing step of the The GLOBALG.A.P standard brings to as Approved National
food chain. together the needs of agricultural Interpretation Guidelines
producers and retailers. It covers all • Guidelines and Supporting
aspects of the production process up documents
to the farm gate. This includes feed,
13
15. • Harmonisation tools referred to as • Livestock housing and facilities The Certification Process
Benchmarking Cross Reference • Livestock health The GLOBALG.A.P certification process
Checklist (BMCL), where applicable
• Medicines consists of five steps:
• Fallen stock disposal • Step A – A proposal is provided
All farm base module
based on the size and nature of an
• Site history and site management • Livestock dispatch
organisation. Once this is accepted
• Record keeping and internal self- the audit process can proceed.
Applies to:
assessment/internal inspection • Step B – There is then an optional
Ruminant base - Cattle and sheep
• Workers health, safety and welfare ‘gap-analysis’ stage assessing an
Dairy organisation’s readiness for the audit.
• Subcontractors
Calf/Young beef This is often useful in identifying
• Waste and pollution management, any weaknesses in systems and in
recycling and re-use Pig
building confidence before the
• Environment and conservation Poultry formal audit.
• Complaints Turkey • Step C – The first part of the formal
audit is the ‘Stage 1 – Assessment
• Recall/withdrawal procedure
Aquaculture Module Process: Document Review’ (Option
• Food defence (not applicable for 2 only). Here the compliance of an
flowers and ornamentals) • Site management
organisation’s documented system is
• GlobalG.A.P status • Reproduction evaluated against the requirements
• Chemicals of the standard with the goal of
• Logo use
achieving a better understanding
• Traceability and segregation • Occupational health and safety
of the nature of the organisation,
(obligatory when producer is • Fish welfare, management planning the rest of the audit as
registered for parallel production/ and husbandry effectively as possible and examining
parallel ownership) • Harvesting key elements of the system at a basic
level. After this, organisations receive
• Sampling and testing
Crops Base Module a report identifying any concerns or
• Feed management observed non-compliances so that
• Traceability
• Pest control immediate action can be taken as
• Propagation material required. All major non-conformities
• Environmental and
• Site history and site management need to be closed out prior to the
biodiversity management
Stage 2 audit.
• Soil management
• Water usage and disposal
• Step D –This is ‘Stage 2 – Assessment
• Fertilizer application
• Post harvest - Process: Certification Audit’ of the
• Irrigation/fertigation mass balance and traceability initial audit process. The audit includes
• Integrated pest management • Post harvest - operations interviews with employees and
examination of records. Observation
• Plant protection products • Social criteria
of an organisation’s working practices
• Equipment determines how compliant its actual
The Benefits processes are with the standard and
Applies to: Certifying on-farm management with its documentation system. At the
Fruit and Vegetables systems against the GLOBALG.A.P end of this stage, the findings of the
requirements provides an organisation audit along with other observations
Combinable Crops
with the following benefits: and opportunities for improvement
Green Coffee are presented to the organisation.
• Enhanced on-farm food safety
Tea Once non-conformities have been
management systems
addressed a technical review of the
• Demonstrates commitment to audit is conducted by an authorised
Livestock base
producing or trading safe food Certification Manager to confirm the
• Site issuance of a certificate.
• Leads to acceptance into the
• Worker health, safety and welfare GLOBALG.A.P community
• Livestock sourcing, identification and • Increases consumer and customer
traceability confidence in product safety
• Livestock feed and water and quality
14
16. • Step E– Unannounced surveillance • Step F – Full recertification audits are mandatory and other selected parts
visits are scheduled between scheduled at twelve-month intervals. of the system are also examined to
certifications. During the visits, At the same time, implementation of ensure they are in line with an audit
the implementation of standard the action plan to address the past plan provided before each visit.
maintenance is reviewed. non-conformities is reviewed. Certain
GLOBALG.A.P CERTIFICATION PROCESS
Year 1
STEP D
STEP A STEP B Issue Certificate STEP E STEP F
Stage 2 after successful
Agree Stage 1 Unannounced Annual
Onsite audit
Contract Document review Audit Recertification
Certification
STEP C For Unannounced Audit:
Optional Option 1 (Individual Grower Certification): Depending on Certification body, sampling
Pre-Audit 10% of all certificates issued by Certification body.
Option 2 (Group Certification): Mandatory
Safe Quality Food (SQF) 1000 Level 2 – Specifications procedure. All non-compliance findings
– Attaining Food Safety from the document review stage again
The SQF 1000 is much the same as the
need to be addressed before the on-
SQF 2000, except that it is designed – Verification site audit can begin. The certification
for primary producers such as growers
– Product Identification Trace & Recall issued lasts one year with a six-month
and farms rather than manufacturers. As
– Site Security surveillance audit for any organisations
with the SQF 2000, which is discussed
only achieving a grade C award. For the
under the section on Manufacturing • Food Safety Fundamentals: Site full details of the certification process
Schemes, the SQF 1000 standard is Requirements, Facilities and see the SQF 2000 section.
made up of three levels, of which level Production Inputs
2 is GFSI approved. The SQF 1000
• Food Safety Fundamentals: PRIMARY AND MANUFACTURING
system consists of the SQF code and
Pre-requisite Programs (Good SCHEMES
its corresponding guidance documents.
Agriculture Practice)
It is a HACCP-based supplier assurance
code designed to meet the food safety • GlobalG.A.P. PrimusGFS
and quality system requirements applied – Genetically Modified Organisms The PrimusGFS standard focuses on
by a primary producer.
– Fertiliser the food safety of agricultural products
The scope and related requirements of designated for human consumption in
– Crop Protection
the SQF 1000 are much the same as for their fresh or in a minorly processed
the SQF 2000 described previously, with – Workers’ Health, Safety & Welfare way. PrimusGFS establishes a series
the exception of one section. The SQF – Environmental of requirements for managing the
2000 has a section titled: Requirements production, handling, processing and
• Implementing SQF 1000 Systems
for Food Contained in Hermetically storing operations, which should be met
Sealed Rigid, Flexible or Semi Rigid • Principles and Application of HACCP for consumer safety.
Containers, which is not part of the SQF • Certifying SQF 1000 Systems The PrimusGFS scheme covers the
1000. Instead the SQF has a section
• SQFI Audit & Certification full supply chain, from pre to post-farm
covering GlobalG.A.P, specifically
Management System and Supplier gate production, with an integrated
laying out requirements in relation
Database supply chain approach. It is a voluntary
to: Genetically Modified Organisms;
worldwide certification scheme
Fertilisers; Crop Protection and; Workers • SQF 1000 Certification Trademark –
certifying agricultural sector products.
Health, Safety and Welfare. Below the Rules for Use
It sets minimum acceptable levels in
requirements are outlined: • Multi-site Certification relation to each of the requirements
• SQF 1000 System Requirements As with the SQF 2000, the certification it includes.
– Commitment process covers a combination of both
desk research and an on-site audit
– Document Control & Records
15
17. IV. A COMPARISON OF THE
GFSI RECOGNISED SCHEMES
Each scheme has a number of similarities as to be GFSI approved the GFSI requirements have to be met. Although, the exact
details can vary from scheme to scheme and there may also be a number of other elements built in to make a scheme specific to a
certain purpose or industry sector. The most all-encompassing schemes are the FSSC 22000 standard, the BRC standard, the
SQF 2000 standard and the IFS. These are compared in more detail below.
STRUCTURAL OVERVIEW OF FSSC 22000, BRC, SQF 2000 AND IFS STANDARDS
How the GFSI requirements are covered in the key global food safety standards:
GFSI REQUIREMENTS FSSC 22000 BRC SQF IFS
Food Safety Management Food Safety and Quality Food Safety and Quality Quality Management
System (FSMS) Management System Management System System
Senior Management
Senior Management
Management Responsibility Commitment and Commitment
Responsibility
Continual Improvement
FOOD SAFETY
Management of Resources Personnel Training of Personnel Resource Management
MANAGEMENT SYSTEM
Food Safety and Quality
Planning and Realisation Specification and
Management System, Production Process
of Safe Products Product Development
Product Control
Internal Audit, Corrective Verification, Corrective
Validation, Verification and Measurement, Analysis
and Preventive Action, and and Preventive Action, and
Improvement of the FSMS and Improvement
Calibration Calibration of Equipment
GOOD MANUFACTURING Site Security, Identify
Site Standard, Human Resources,
PRACTICES, GOOD Planning and Realisation of Preserved Food, Product
Product Control, Food Hygiene Requirements
DISTRIBUTION PRACTICES, GOOD Safe Products and PAS220 ID, Trace and Withdraw, and
Process Control, Personnel (clauses 4.6-4.18)
AGRICULTURAL PRACTICES Food Safety Fundamentals
Planning and Realisation
HAzARD ANALYSIS Specification and Product
of Safe Products,
AND CRITICAL CONTROL Food Safety Plan – HACCP Development, Attaining HACCP
Validation, Verification and
POINT (HACCP) Food Safety
Improvement of the FSMS
16
18. A SECTION-BY-SECTION COMPARISON Management Commitment/ Management review
OF THE KEY SCHEMES Responsibility All schemes require senior management
Most of schemes require an to review the verification of the food
General Requirements organisational chart and job descriptions safety management system and HACCP
to be in place. They all place great plan, at pre-arranged intervals, to ensure
The general requirements for all
emphasis on management commitment its continuing suitability, adequacy
schemes are similar in that they require
to implement and maintain an effective, and effectiveness. Review of the food
a competently implemented, regularly
continually upgraded food safety safety system is also required in the
evaluated, continually improved,
system demonstrated through regularly event of any change that could affect
HACCP-based food safety
scheduled management review food safety. More specifically, the IFS
management system.
meetings, business continuity planning, scheme requires that the management
establishment of effective channels review includes: buildings; supply
Food Safety Policy
for internal/external communication systems; equipment and transport; staff
All schemes require a food safety policy and the appointment of a food safety facilities, environmental conditions;
that covers the scope of business team and leader. This team leader safety and security at work; hygienic
activities. This policy should involve must be responsible for developing, condition and; workplace design
the implementation of a HACCP-based implementing and communicating and external influences (e.g. noise,
food safety system that complies with the elements of the food safety vibration). The IFS also requires that
regulatory/customer requirements, is management system to company the result of the review is included
internally audited, continually improved personnel and must have the authority in subsequent budgeting. The BRC
and effectively communicated to to act on management’s behalf on food scheme requires that the review process
company personnel. This policy must be safety issues. The SQF scheme calls includes: previous management review
supported within the organisation and this team leader the ‘SQF Practitioner’, documents; action plans/time frames;
measurable objectives need to be set specifically requiring that this individual customer performance indicators;
and tracked. The IFS scheme specifically be a full time employee of the company, complaints and feedback; incidents;
requires the inclusion of environmental be trained in HACCP principles and corrective actions; out-of-specification
and social responsibility, while the BRC is able to demonstrate a working results and; non-conforming material
scheme requires that an organisation’s knowledge of the applicable SQF code as well as; developments in scientific
policy includes a provision to ensure requirements. The SQF scheme also information associated with the products
that food safety system certification requires that the organisational structure in scope. The SQF scheme requires the
does not expire and that the organisation within the company be communicated review to include: policies; internal and
has purchased a copy of the current to all staff. The BRC scheme specifically external audit findings; corrective action;
issue of the BRC Global Standard for requires that the most senior production and customer complaints. Records of
Food Safety. or operations manager on site must amended documents, validation and
attend the opening and closing changes to the SQF system also need to
Food Safety Manual meetings of the audit for Global be maintained.
Standard for Food Safety certification
All schemes require a food safety
and that senior management must
manual or a documented system to
ensure all non-conformities identified at
be in place that covers or references
the previous audit against the standard
procedures that control significant food
are effectively actioned.
safety hazards. None of the schemes
are specific about the title or format of
such documentation, as long as it exists.
17
19. Resource management which have an effect on product safety stored, accessible procedures in
and that a regular review process is in place for the determination and
All schemes require that senior
place to ensure these specifications are implementation of timely, verified
management provide adequate
kept up to date. corrective action in the event of any non-
resources to ensure that the food
conformity relating to product safety.
safety management system continues
Internal Audit The corrective action must include
to be effective in meeting regulatory
actions to bring the process back under
and customer requirements, including All schemes require the organisation
control and to prevent recurrence of the
responsibility for competent provision of to have an internal audit system in
non-conformity.
outsourced services or activities. place that covers all systems and
procedures critical to product safety
Control of non-conforming product
Documentation and all applicable elements of the
scheme. This internal audit must be All schemes require that the
All schemes require documented
performed at defined frequency, by organisation has documented, securely
procedures to demonstrate conformance
trained personnel independent of stored, accessible procedures in place
with the specified scheme requirements
activities audited, with documented to ensure that any product that does not
and records to demonstrate the
results and prompt follow-up to correct conform to food safety requirements
effective control of processes and food
any identified non-conformities. The IFS is clearly identified and controlled to
safety management. Customer and
scheme states examples of verification prevent unintended use or delivery.
supplier related specifications related
activities, including analysis, sampling,
to food safety must also be controlled.
and evaluation. The BRC scheme Product release
Requirements include verified issuance
states that examples of verification
and consistent versions, as well as All schemes require that the organisation
activities include a review of records
secure storage of such documents has appropriate procedures in place to
where acceptable limits have been
in a manner that allows them to be ensure that food safety requirements are
exceeded, review of incidents of product
accessible for a retention time that adequately met prior to product release.
withdrawal or recall. The BRC scheme
meets customer and legal requirements.
also requires that internal audit results
Both the BRC and SQF schemes
must be communicated to the HACCP Purchasing, supplier
require that documents are in a
food safety team. The SQF scheme approval/monitoring
language or languages spoken by the
requires that an internal audit schedule All schemes require that the organisation
organisation’s staff and that they are
is in place, describing the verification controls purchasing processes to ensure
sufficiently detailed.
activities, their frequency of completion that all externally sourced items conform
and the person responsible for to food safety requirements and that
Specifications
each activity. procedures are in place for approval and
All schemes require documented continued monitoring of its suppliers.
specifications for all items and services Corrective action The results of supplier evaluations and
(including utilities, transport and follow up actions must be recorded.
All schemes require that the
maintenance) purchased or provided
organisation has documented, securely
18