This document provides guidelines for Apotex's global supply chain security policy regarding tampering and counterfeiting controls. It outlines roles and responsibilities for monitoring risks like product adulteration, counterfeiting, illegal diversion, and cargo theft. Quality risk management processes are used to understand these risks and identify factors like certain geographies, products, or transportation methods that require increased controls and auditing to mitigate security issues in the supply chain.
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.
This document provides guidelines on Good Manufacturing Practices (GMP) for pharmaceutical products. It discusses key aspects of a Pharmaceutical Quality System including quality management, GMP, quality control, product quality reviews, and quality risk management. The guidelines state that senior management is responsible for establishing an effective quality system to ensure product quality and compliance. It also outlines good documentation practices, change control, outsourcing, complaints handling, and self-inspections which are important parts of GMP and pharmaceutical quality assurance.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
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.
Training in a CGMP environment is very important as it is a very important requirement of the regulations. Training is simply one of the means to fill the gaps of performance between the actual results and the expected results.
PIC/S Guide to GMP PE009-13 - Key changes to Annex 15 - Qualification and val...TGA Australia
The TGA has now legislated version 13 of the PIC/S guide to GMP for medicinal products with a transition period for implementation ending at the end of 2018. Some of the biggest changes in this version were in Annex 15 – Qualification and Validation. This has an impact across all areas in including small to medium sized manufacturers as well as sponsors who need to understand the impact in their supply chain including contract manufacturing and storage and transportation.
This presentation discusses approaches for determining the number of process performance qualification (PPQ) batches needed based on a risk-based assessment of product and process knowledge and the control strategy. It describes evaluating the risks associated with product attributes, process parameters, and controls. Factors that influence risk, such as raw material variability, equipment capabilities, and process performance history are reviewed. The goal is to justify the minimum number of PPQ batches required based on the level of process understanding and control.
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.
This document provides guidelines on Good Manufacturing Practices (GMP) for pharmaceutical products. It discusses key aspects of a Pharmaceutical Quality System including quality management, GMP, quality control, product quality reviews, and quality risk management. The guidelines state that senior management is responsible for establishing an effective quality system to ensure product quality and compliance. It also outlines good documentation practices, change control, outsourcing, complaints handling, and self-inspections which are important parts of GMP and pharmaceutical quality assurance.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
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.
Training in a CGMP environment is very important as it is a very important requirement of the regulations. Training is simply one of the means to fill the gaps of performance between the actual results and the expected results.
PIC/S Guide to GMP PE009-13 - Key changes to Annex 15 - Qualification and val...TGA Australia
The TGA has now legislated version 13 of the PIC/S guide to GMP for medicinal products with a transition period for implementation ending at the end of 2018. Some of the biggest changes in this version were in Annex 15 – Qualification and Validation. This has an impact across all areas in including small to medium sized manufacturers as well as sponsors who need to understand the impact in their supply chain including contract manufacturing and storage and transportation.
This presentation discusses approaches for determining the number of process performance qualification (PPQ) batches needed based on a risk-based assessment of product and process knowledge and the control strategy. It describes evaluating the risks associated with product attributes, process parameters, and controls. Factors that influence risk, such as raw material variability, equipment capabilities, and process performance history are reviewed. The goal is to justify the minimum number of PPQ batches required based on the level of process understanding and control.
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 provides guidance on good manufacturing practices for the production of active pharmaceutical ingredients. It discusses quality management, personnel, facilities, equipment, documentation, materials management, production controls, and other quality assurance aspects of API manufacturing. The objective is to help ensure APIs meet quality and purity standards.
This document discusses guidelines for assessing elemental impurities in pharmaceutical products according to ICH Q3D. It describes a risk-based approach to evaluating potential sources of elemental impurities from drug substances, excipients, equipment and processing aids. Specific approaches are provided for assessing impurities from metal catalysts, water sources, and packaging materials. The presentation emphasizes controlling impurities through an understanding of manufacturing processes and applying appropriate testing and control strategies.
This presentation presents points to consider for building and using models in the regulated pharmaceutical industry and offers examples of how models can play a part in the Quality by Design (QbD) framework.
This document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It defines GMP as ensuring products are consistently manufactured and controlled to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and current. Quality is defined as a product's fitness for purpose. GMP is designed to minimize risks that cannot be eliminated through testing, such as contamination or incorrect labeling. Adhering to GMP is important to ensure medicines contain the proper ingredients and doses. The document outlines key aspects of GMP, including facilities, equipment, documentation, validation, training, and audits.
This presentation correlates the requirements of Annex 11 guidelines to other official regulations and guidance documents.
The correlation is organized in a tabular format.
In the row lists the contents of Annex 11 together with the paragraph numbers.
Rest of the rows correlate the section numbers of
Annex 11 Versions 1993
US FDA 21 CFR Part 211
US FDA Part 820 and
US FDA 21 CFR Part 11
current Good Manufacturing Practices (cGMP)Dr. Samia
The document discusses current good manufacturing practices (cGMP) regulations established by the FDA to ensure minimum quality standards for drug products. It provides details on cGMP requirements for facilities, equipment, personnel, production, quality control, documentation, packaging and labeling. Non-compliance with cGMP can result in regulatory actions from the FDA such as delays in drug approval, removal of products from the market or restrictions on applications.
GMP (Good Manufacturing Practices) are procedures and principles that help ensure pharmaceutical products are consistently produced and controlled according to quality standards appropriate for their intended use. A key principle of GMP is that quality must be built into every step of the manufacturing process rather than tested into the final product. GMP guidelines cover all aspects of production from facilities and equipment to staff training to ensure minimum risks like contamination, incorrect labeling, or insufficient active ingredients. Strict adherence to GMP procedures and documentation is important to ensure medicines are safe, effective and meet their intended purpose.
Best practice part b ingredient, recipe, and labeling management-Woody WangSimba Events
The document discusses best practices for managing ingredients, recipes, formulas, and labeling in the food industry. It covers managing supplier specifications of raw materials, creating and managing formulas and production processes, and managing labeling requirements. The system allows inputting raw material data, generating nutrition information, setting loss factors during production, and creating label specifications to ensure compliance.
This document provides information about product recalls in the Philippines. It defines a product recall as the removal of a product from the market due to defects or safety issues. Recalls can be initiated voluntarily by a company or ordered by the Philippine Food and Drug Administration (FDA). The FDA will classify recalls as Class I, II, or III based on the health hazard level. For ordered recalls, the FDA notifies companies and specifies actions to be taken. Companies must coordinate recall strategies and reports with the FDA, and recalls should be treated urgently to protect public health.
The document provides guidance on good manufacturing practices (GMP) for manufacturing active pharmaceutical ingredients (APIs) according to ICH Q7 guidelines. It discusses quality management, facilities and equipment requirements, documentation, materials management, production controls, validation, and specific guidance for APIs made by cell culture/fermentation. The objective is to help ensure APIs meet quality and purity standards. It provides recommendations but does not replace regulatory requirements.
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
1) GMP (Good Manufacturing Practice) guidelines are important regulations that help ensure animal vaccines and other drugs/medical products are produced safely and are effective. They cover all aspects of production from materials to equipment to staff training.
2) Key components of GMP include quality management, quality control, sanitation, validation, documentation and more. Strict adherence to GMP helps reduce risks like contamination and errors that could harm patients.
3) For animal vaccines specifically, following GMP is critical given the live organisms involved and safety precautions needed. Facilities must be designed to properly handle biosafety requirements as well as aseptic processing.
The document is a presentation on post-approval changes to bulk active chemicals. It discusses FDA guidance called BACPAC (Bulk Active Chemicals & Post Approval Changes) which provides recommendations for post-approval changes to drug substance synthesis, including site, scale and equipment changes as well as specification and manufacturing process changes. The guidance covers assessing equivalence after changes and determining the appropriate reporting category based on the potential effects of changes.
c gmp (current good manufacturing practices)Rohit K.
cGMP (Current Good Manufacturing Practices) regulations provide the framework for ensuring quality control during pharmaceutical manufacturing. The regulations are divided into parts 210 and 211. Part 211 addresses good manufacturing practices for finished pharmaceuticals and is further divided into 11 subparts covering organization, facilities, equipment, production, packaging, labeling, quality control, and more. The goal of cGMP is to ensure identity, strength, quality and purity of drugs through strict control of manufacturing and monitoring.
Tips and Traps for SQF 7.1: Understanding Top 10 Non-conformancesSAIGlobalAssurance
This document provides a summary of a webinar on understanding the top non-conformances in SQF 7.1 certification. It discusses the relationship between SQF and GFSI and the changes between SQF Code editions. The webinar focuses on the most common non-conformances found during SQF certification, re-certification, and surveillance audits for Module 2 (SQF system elements) and Module 11 (food processing). Management responsibility, business continuity planning, food safety plans, internal audits, and corrective action were identified as the most common themes among non-conformances. The webinar provides tips on compliance and ensures understanding of SQF requirements for these areas
This document outlines standard operating procedures for product recalls. It defines three classes of recalls based on risk to health, with Class I being potentially life-threatening. It describes initiating a recall due to complaints, failed tests, or health risks. It also details the preliminary assessment, identifying the root cause, deciding whether to recall, notifying departments and recipients, segregating products, monitoring recall progress, reporting, and actions to prevent future issues.
This document summarizes guidelines published by the World Health Organization (WHO) on Quality Risk Management (QRM) for pharmaceuticals. The WHO guidelines were published in 2013 and provide an updated, risk-based approach for regulators and manufacturers to ensure quality, safety and efficacy of medicines. Key points include:
- QRM is a systematic process to assess, control, communicate and review risks to product quality throughout the product lifecycle. It can be applied both proactively and retrospectively.
- For regulators, QRM allows prioritization of inspection resources based on product risks. For manufacturers, it encourages innovation through science-based quality decisions.
- The level of QRM should be commensurate with risk
In the last year or so the FDA and the EMA have issued new guidance/ draft guidance on "Process Validation".These align process validation activities with a product lifecycle concept and the International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The earlier guidelines were developed before the elaboration of the new ICH guidelines.With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria. ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. ICH Q8 refers to an ‘enhanced’ approach to pharmaceutical development which includes an alternative to the traditional process validation.
Continuous process verification [see definition in ICH Q8(R2) glossary] can be utilised in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle.
There is now a new paradigm in process validation. This presentation has been prepared from material available from FDA , EMA and ICH for beginners to have an overview of the new paradigm.
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 provides guidance on good manufacturing practices for the production of active pharmaceutical ingredients. It discusses quality management, personnel, facilities, equipment, documentation, materials management, production controls, and other quality assurance aspects of API manufacturing. The objective is to help ensure APIs meet quality and purity standards.
This document discusses guidelines for assessing elemental impurities in pharmaceutical products according to ICH Q3D. It describes a risk-based approach to evaluating potential sources of elemental impurities from drug substances, excipients, equipment and processing aids. Specific approaches are provided for assessing impurities from metal catalysts, water sources, and packaging materials. The presentation emphasizes controlling impurities through an understanding of manufacturing processes and applying appropriate testing and control strategies.
This presentation presents points to consider for building and using models in the regulated pharmaceutical industry and offers examples of how models can play a part in the Quality by Design (QbD) framework.
This document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It defines GMP as ensuring products are consistently manufactured and controlled to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and current. Quality is defined as a product's fitness for purpose. GMP is designed to minimize risks that cannot be eliminated through testing, such as contamination or incorrect labeling. Adhering to GMP is important to ensure medicines contain the proper ingredients and doses. The document outlines key aspects of GMP, including facilities, equipment, documentation, validation, training, and audits.
This presentation correlates the requirements of Annex 11 guidelines to other official regulations and guidance documents.
The correlation is organized in a tabular format.
In the row lists the contents of Annex 11 together with the paragraph numbers.
Rest of the rows correlate the section numbers of
Annex 11 Versions 1993
US FDA 21 CFR Part 211
US FDA Part 820 and
US FDA 21 CFR Part 11
current Good Manufacturing Practices (cGMP)Dr. Samia
The document discusses current good manufacturing practices (cGMP) regulations established by the FDA to ensure minimum quality standards for drug products. It provides details on cGMP requirements for facilities, equipment, personnel, production, quality control, documentation, packaging and labeling. Non-compliance with cGMP can result in regulatory actions from the FDA such as delays in drug approval, removal of products from the market or restrictions on applications.
GMP (Good Manufacturing Practices) are procedures and principles that help ensure pharmaceutical products are consistently produced and controlled according to quality standards appropriate for their intended use. A key principle of GMP is that quality must be built into every step of the manufacturing process rather than tested into the final product. GMP guidelines cover all aspects of production from facilities and equipment to staff training to ensure minimum risks like contamination, incorrect labeling, or insufficient active ingredients. Strict adherence to GMP procedures and documentation is important to ensure medicines are safe, effective and meet their intended purpose.
Best practice part b ingredient, recipe, and labeling management-Woody WangSimba Events
The document discusses best practices for managing ingredients, recipes, formulas, and labeling in the food industry. It covers managing supplier specifications of raw materials, creating and managing formulas and production processes, and managing labeling requirements. The system allows inputting raw material data, generating nutrition information, setting loss factors during production, and creating label specifications to ensure compliance.
This document provides information about product recalls in the Philippines. It defines a product recall as the removal of a product from the market due to defects or safety issues. Recalls can be initiated voluntarily by a company or ordered by the Philippine Food and Drug Administration (FDA). The FDA will classify recalls as Class I, II, or III based on the health hazard level. For ordered recalls, the FDA notifies companies and specifies actions to be taken. Companies must coordinate recall strategies and reports with the FDA, and recalls should be treated urgently to protect public health.
The document provides guidance on good manufacturing practices (GMP) for manufacturing active pharmaceutical ingredients (APIs) according to ICH Q7 guidelines. It discusses quality management, facilities and equipment requirements, documentation, materials management, production controls, validation, and specific guidance for APIs made by cell culture/fermentation. The objective is to help ensure APIs meet quality and purity standards. It provides recommendations but does not replace regulatory requirements.
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
1) GMP (Good Manufacturing Practice) guidelines are important regulations that help ensure animal vaccines and other drugs/medical products are produced safely and are effective. They cover all aspects of production from materials to equipment to staff training.
2) Key components of GMP include quality management, quality control, sanitation, validation, documentation and more. Strict adherence to GMP helps reduce risks like contamination and errors that could harm patients.
3) For animal vaccines specifically, following GMP is critical given the live organisms involved and safety precautions needed. Facilities must be designed to properly handle biosafety requirements as well as aseptic processing.
The document is a presentation on post-approval changes to bulk active chemicals. It discusses FDA guidance called BACPAC (Bulk Active Chemicals & Post Approval Changes) which provides recommendations for post-approval changes to drug substance synthesis, including site, scale and equipment changes as well as specification and manufacturing process changes. The guidance covers assessing equivalence after changes and determining the appropriate reporting category based on the potential effects of changes.
c gmp (current good manufacturing practices)Rohit K.
cGMP (Current Good Manufacturing Practices) regulations provide the framework for ensuring quality control during pharmaceutical manufacturing. The regulations are divided into parts 210 and 211. Part 211 addresses good manufacturing practices for finished pharmaceuticals and is further divided into 11 subparts covering organization, facilities, equipment, production, packaging, labeling, quality control, and more. The goal of cGMP is to ensure identity, strength, quality and purity of drugs through strict control of manufacturing and monitoring.
Tips and Traps for SQF 7.1: Understanding Top 10 Non-conformancesSAIGlobalAssurance
This document provides a summary of a webinar on understanding the top non-conformances in SQF 7.1 certification. It discusses the relationship between SQF and GFSI and the changes between SQF Code editions. The webinar focuses on the most common non-conformances found during SQF certification, re-certification, and surveillance audits for Module 2 (SQF system elements) and Module 11 (food processing). Management responsibility, business continuity planning, food safety plans, internal audits, and corrective action were identified as the most common themes among non-conformances. The webinar provides tips on compliance and ensures understanding of SQF requirements for these areas
This document outlines standard operating procedures for product recalls. It defines three classes of recalls based on risk to health, with Class I being potentially life-threatening. It describes initiating a recall due to complaints, failed tests, or health risks. It also details the preliminary assessment, identifying the root cause, deciding whether to recall, notifying departments and recipients, segregating products, monitoring recall progress, reporting, and actions to prevent future issues.
This document summarizes guidelines published by the World Health Organization (WHO) on Quality Risk Management (QRM) for pharmaceuticals. The WHO guidelines were published in 2013 and provide an updated, risk-based approach for regulators and manufacturers to ensure quality, safety and efficacy of medicines. Key points include:
- QRM is a systematic process to assess, control, communicate and review risks to product quality throughout the product lifecycle. It can be applied both proactively and retrospectively.
- For regulators, QRM allows prioritization of inspection resources based on product risks. For manufacturers, it encourages innovation through science-based quality decisions.
- The level of QRM should be commensurate with risk
In the last year or so the FDA and the EMA have issued new guidance/ draft guidance on "Process Validation".These align process validation activities with a product lifecycle concept and the International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The earlier guidelines were developed before the elaboration of the new ICH guidelines.With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria. ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. ICH Q8 refers to an ‘enhanced’ approach to pharmaceutical development which includes an alternative to the traditional process validation.
Continuous process verification [see definition in ICH Q8(R2) glossary] can be utilised in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle.
There is now a new paradigm in process validation. This presentation has been prepared from material available from FDA , EMA and ICH for beginners to have an overview of the new paradigm.
Adoption of the pics guide to gmp pe009 13TGA Australia
The document discusses the adoption of the latest version of the PIC/S Guide to GMP by the Australian regulatory authority. Key points include:
- Australia aims to adopt the latest international GMP standards to maintain equivalence and assurance for international markets.
- The timeline for adoption includes notifying industry in 2017/2018 and full implementation by January 2019.
- Major changes in the new PIC/S Guide include new requirements for quality manuals, increased emphasis on senior management involvement, additional responsibilities for quality roles, and clarification of document and data integrity standards.
- Annex 15 on validation was expanded to provide more detail on validation master plans and checks to ensure data integrity.
Quality assurance and quality control are important concepts in pharmaceutical manufacturing. Quality assurance refers to planned and systematic activities that ensure quality in processes, while quality control refers to activities that ensure quality in products. Some key differences are that quality assurance focuses on preventing defects through proper processes, while quality control identifies defects in finished products. Total quality management aims to produce perfect products through quality measures at every stage of production and requires team effort across an organization.
This document provides an overview of a training on good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs). The training will cover quality management, personnel, facilities, equipment, documentation, production, validation, laboratory control, stability testing, contract manufacturing, and agents/brokers. It discusses the introduction and scope of GMP guidelines for APIs. Key points include ensuring APIs meet quality and purity standards, applying GMP from receipt of starting materials through packaging and distribution, and the responsibilities of quality units.
This document outlines a training module on good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs). The training is divided into three parts that will cover quality management, personnel, facilities, equipment, documentation, production, validation, laboratory control, stability testing, and contract manufacturing. The training introduces GMP guidelines for APIs and emphasizes that APIs must meet quality and purity standards. It also discusses key GMP topics like change control, complaints, responsibilities of quality units, facilities design, sanitation, and utilities.
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
The Impact of BRC Food 7: Most Common Non-ConformitiesTraceGains
The 7th issue of the BRC Global Standard for Food Safety began audits July 1, 2015, and we now have almost 2 months’ worth of results. The information coming back paints a picture of readiness of sites for the changes, and a picture of what they have had to prepare for successful continuation of certification is forming.
The session will cover the most significant changes the 7th issue brought forward, why they were included, what BRC expected, and what impact the changes are actually having on the industry.
Specifically, the session will focus on:
-The top non-conformities seen in issue 7 audits
-Strategies for your operation to learn from these early audits
-What changes have been made, and why they make the BRC Global Standards the leading certification for food safety.
BRC is the leading and most recognized of the GFSI benchmarked programs, and is used at manufacturing sites, and by customers as a leading certification around the world. John Kukoly, our presenter, is the head of BRC activities in the Americas.
Process validation is establishing documented evidence that a process will consistently produce a product meeting predetermined specifications. This presentation discusses process validation, including its definition, scope, objectives, types (prospective, retrospective, concurrent, revalidation), stages, responsibilities of different departments, protocols, sampling procedures, acceptance criteria, and reports. Key aspects of process validation include protocols, sampling plans, specifications, batch execution records, and data analysis to ensure a process is capable of reproducible commercial manufacturing of pharmaceutical products that meet quality standards.
Process Manufacturing Ensuring Food Safety, white paper, English, USPatti Stoll
This document discusses how process manufacturers can ensure food safety through active HACCP management using Infor solutions. It describes the seven principles of HACCP for identifying and controlling food safety hazards. Infor PLM Optiva, EAM, and Event Management help manufacturers address these principles by providing visibility into materials and processes, managing production equipment maintenance, and enabling instant response to critical process changes or exceptions. Together these solutions allow manufacturers to proactively prevent food contamination through an integrated HACCP program.
HACCP Training Material VER 002 05.05.15.pptxDeparted Moon
This document provides an overview of Hazard Analysis and Critical Control Points (HACCP) for an in-house training course. It defines HACCP and explains that it is a systematic approach to identify, evaluate, and control food safety hazards. The document outlines the 7 principles of HACCP, including conducting a hazard analysis, determining critical control points, establishing critical limits, and implementing monitoring, corrective action, and verification procedures. It also discusses prerequisite programs that must be in place before implementing HACCP.
This document summarizes the key changes between Issues 7 and 8 of the BRC Global Standard for Food Safety. Some notable changes include new requirements for developing and reviewing food safety culture, conducting root cause analysis for non-conformances and incidents, assessing cyber security risks, validating CIP systems, conducting environmental monitoring, and establishing shelf life through trials that reflect expected conditions throughout the supply chain. Overall, the changes strengthen requirements for food safety management systems, continuous improvement, and proactively addressing risks.
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
Presentation Updating the Manufacturing Principles TGA Australia
The document discusses updates to the PIC/S Guide to GMP (PE009). It provides an overview of the processes used by the EMA, PIC/S, and TGA to adopt and implement GMP updates. It outlines some of the key changes between PE009-13 and the previous version, and discusses future revisions including changes expected in PE009-14 regarding premises and equipment, production, complaints and recalls. The speaker emphasizes that GMPs are updated regularly to address risks to patient health and ensure international equivalence, and that manufacturers should follow the TGA's transition plan to adopt the latest requirements.
This document outlines Spotless' Food Safety Standard for Suppliers. It establishes Spotless' commitment to ensuring food and beverages purchased throughout the business are sourced from reputable suppliers that meet the requirements of Food Standards Australia New Zealand (FSANZ).
The standard applies to all Spotless approved food and beverage suppliers. It provides clear requirements for suppliers to meet based on the FSANZ Food Standards Code and state/territory food acts and regulations. Suppliers are expected to comply with the standard and will undergo inspections and audits by Spotless and approved certification agencies.
High, medium, and low risk suppliers will be categorized based on purchase groups and audited annually or biannually depending on
The document discusses several topics related to quality assurance of drugs, including emerging trends, key recommendations, tasks for corporate quality assurance units, communication strategies, validation variations, product integrity, managing suppliers and third parties, hazard analysis and critical control points (HACCP), guidelines for applying HACCP, and good automated manufacturing practices (GAMP). Some of the main points discussed are the changing quality assurance environment and need for continuous improvement, effective communication across the organization, risk-based auditing, ensuring product validation is continuously updated, and employing quality control and validation strategies according to ICH standards.
BRC global standard for food safety short training guideNaizil Kareem
The document discusses the requirements for meeting the BRC Global Standard for Food Safety. It covers topics such as management commitment, HACCP systems, prerequisite programs, quality management systems, food safety plans, and purchasing procedures. The main points are that organizations must implement a comprehensive food safety system based on HACCP principles, have documented food safety and quality policies, audit and approve suppliers, and review all food safety plans and procedures annually or when changes occur. Senior management must also demonstrate commitment through reviews and resource allocation.
This document discusses the Hazard Analysis and Critical Control Point (HACCP) system for ensuring food safety. It defines HACCP and explains its seven principles for identifying and controlling food safety hazards. The document also outlines the steps to implement a HACCP program in a food processing plant, including forming a HACCP team, conducting a hazard analysis and identifying critical control points, establishing monitoring procedures, and verifying that the HACCP system is working properly. The goal of HACCP is to prevent food safety hazards through control at critical points during food production rather than relying on end product inspection.
This document outlines a risk-based approach for classifying deficiencies found during inspections. Deficiencies are described as instances of non-compliance and are classified based on whether they result from a defective system or a failure to comply with the system. Deficiencies can be critical, major, or minor/other observations. Critical observations pose a significant risk of patient harm, while major observations indicate major deviations from good practices. The document also describes Pfizer's 10-step process for conducting a quality risk management assessment, which includes identifying risks, defining risk components and scales, applying a risk analysis tool, defining risk mitigation measures, and documenting the assessment.
World economy charts case study presented by a Big 4
World economy charts case study presented by a Big 4
World economy charts case
World economy charts case study presented by a Big 4
World economy charts case study presented by a Big 4World economy charts case study presented by a Big 4
World economy charts case study presented by a Big 4
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MUTUAL FUNDS (ICICI Prudential Mutual Fund) BY JAMES RODRIGUESWilliamRodrigues148
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ZKsync airdrop of 3.6 billion ZK tokens is scheduled by ZKsync for next week.pdf
1234 ingles
1. GLOBAL POLICY
Division:
Title:
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Page
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SUPPLY CHAIN SECURITY – TAMPERING AND COUNTERFEIT CONTROLS
1.0 Proposito
1.1 Para proporcionar la dirección y los requisitos de medidas y acciones tomadas para mantener la integridad de
Apotex global de seguridad de la cadena de suministro.
1.1.1
1.1.2
1.1.3
Tener conciencia y visibilidad a las señales de alerta en el medio ambiente.
Aplicar principios de gestión de riesgos.
Para desarrollar programas específicos para abordar la adulteración, falsificación, robo y desvíos ilegales.
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2.0 Scope
2.1
2.2
2.3
2.4
Esta Política Global se aplica a la Apotex terminado de grupo de empresas productoras de formas de dosificación.
También es aplicable a los afiliados de Apotex y los centros de distribución de Apotex.
Esta Política Global puede usarse para la evaluación y supervisión de Apotex terceros organismos .
Esta Política Global establece las pautas escritas describiendo los requisitos y consideraciones para
implementar eficazmente las medidas de seguridad de cadena de suministro.
La cadena de suministro es un proceso complejo que abarca muchas regiones geográficas e implica a
numerosos partidos. Para garantizar la seguridad de la cadena de suministro, deben estar involucrados varios
grupos funcionales (enfoque integral) sobre el ciclo vital de la cadena de suministro.
2.4.1 Este enfoque integrado puede facilitar la seguridad de la cadena de suministro al aumentar el sistema de
calidad farmacéutica para prevenir y detectar la adulteración, falsificación, robo y desvío ilegal.
Apotex puede ser capaz de mitigar ciertos riesgos asociados con materiales adulterados, falsificados,
robados o desviados y entrar en la cadena de suministro mediante la aplicación de productos acabados
apropiados principios y estrategias.
2.4.2
3.0 Owner Organizational Unit
AGO-Global QA Policy and Systems.
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4.0 General Training Requirements
4.1 Como mínimo, directores, directivos y gerentes de las siguientes áreas funcionales deben ser entrenados en cada sitio:
-
-
calidad
Manufacturing Operations.for the bold
Research and Development. 123
Desarrollo de productos y operaciones técnicas.
Engineering Services. red pencil
Warehouse and Distribution. Red Pencil
Sales and Marketing Ventas y Marketing. 1.2 libro. 1.2 book
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-
-
-
-
4.2
5.0
Otro personal de la organización puede ser entrenados por la discreción de la administración del sitio.
Associated Documents
Document #
QM
GPOL-002
GPOL-007.
GPOL-012
GPOL-014
GPOL-015
GPOL-023
GPOL-027
GPOL-029
GSOP-029-001
Document Title
Apotex Quality Manual
Management Controls – Governance,
Management Notification, Management
Review
Manufacturing, Packaging, and Labelling
Controls
Material Controls. 1.2.3.
Quality Risk Management. 1.2.3.
Audit Program. 1.1.1.1.
Warehouse Controls. 1.1.1.1
Supplier Qualification Program. 1.1.1.1
Distribution Controls. 1.1.11.
Shipping Under Quarantine. 1.1.1.11.
Relationship
Governing Quality Manual.12 book
Associated Global Policy
Associated Global Policy
Associated Global Policy
Associated Global Policy
Associated Global Policy
Associated Global Policy
Associated Global Policy
Associated Global Policy
Associated Global SOP. 1.2
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6.0 Definitions
Term
Adulteration.1.1.1.1.
Apotex
Cargo Theft. 1.1.11.
Counterfeit. 1.1.11.
Customer.1.1.1..1.1.
Distributor/Broker. 1.1.1.1.
Economically
Motivated
Adulteration.1.1.1.
Environmental
Scanning.1.1.1.
First Tier Supplier.1.1.1.1
Definition
The addition of a foreign or inferior substance or element to a drug, resulting
in the drug not being w hat it is purported to be.
Apotex group of companies producing finished dosage forms. Term also
includes the affiliates and distribution centers.
The theft of finished pharmaceuticals during transportation or w arehousing.
The deliberate and fraudulent mislabelling of a drug w ith respect to identity
and/or source.
Where the first change in ow nership of a product takes place.
A person or entity that sells, distributes, transports, and/or forw ards materials,
but does not actually manufacture the material.
The fraudulent, intentional substitution or addition of a substance in a product
for the purpose of increasing the apparent value of the product or reducing the
cost of its production, i.e. for economic gain.
A process for review ing external information w hich may have an impact on
selected targets. It involves the collection and analysis of information relevant
to pre-defined targets.
A first tier supplier is a supplier w ho directly invoices the organization for
goods and/or services rendered directly by the first tier supplier to the
organization as a customer.
Diverting finished products from the intended supply chain, w here the
intended supply chain refers to the law ful channels by w hich a pharmaceutical
manufacturer transfers drug product to the first legal ow ner.
A systematic process for the assessment, control, communication and review
of risks to the quality of the pharmaceutical product throughout the product
life-cycle.
The systematic use of information to identify potential sources of harm
(hazards) referring to the risk question or problem description.
A second tier supplier is a supplier w ho invoices a first tier supplier for goods
and/or services w hich w ill ultimately be part of the first tier supply organization.
New information indicating the potential for economically motivated
adulteration of a material or product, the use of counterfeit material, or the
illegal diversion of legitimate product into unlaw ful channels.
A particular vulnerable material or physical point in the supply chain w here
adulteration, counterfeiting, or illegal diversion could occur. Risk management
approaches should be used to help identify targets.
A third tier supplier is a supplier w ho invoices a second tier supplier.
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Illegal Diversion.1.1.11.
Quality Risk
Management (QRM)
Risk Identification.1.1.1.1.
Second Tier Supplier.1.1.1.1
Signal.
Target..1.1.1.1.
Third Tier Supplier.1.1.1.
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7.0 Roles and Responsibilities.
Role
President & C.O.O.
Responsibility
-
-
-
Review and Approve this Global Policy
Proporcionar los recursos necesarios para la aplicación efectiva de esta Política
Global.
Garantizar una supervisión eficaz por la supervisión Ejecutiva Comité.
Review and Approve this Global Policy
Proporcionar supervisión de calidad de esta Política Global.
Garantizar una supervisión eficaz por la supervisión Ejecutiva Comité.
Review this Global Policy
Ensure the Deployment / Implementation of this Global Policy
at applicable Global Apotex sites
Review this Global Policy
Asegurar la implementación / ejecución de esta Política Global dentro de las
funciones de desarrollo de producto.
Review this Global Policy
Asegurar la implementación / funciones de aplicación de esta Política Global en
asuntos reguladores & científico.
Review this Global Policy
Ensure the Deployment / Implementation of this Global Policy
w ithin R&D QA functions
Review this Global Policy
Ensure the Deployment / Implementation of this Global Policy
at applicable Global Apotex sites
Review this Global Policy
Ensure the Deployment / Implementation of this Global Policy
at applicable Global Apotex sites
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VP,
Corporate Quality & Compliance
-
-
-
EVP,
Global Supply Operations
-
-
-
-
-
-
-
-
-
-
-
-
Senior VP,
Product Development
Senior VP,
Scientific & Regulatory Affairs
Global Director,
R&D QA.
Global Director,
External Quality
Global Director,
QA Audit
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Role
Global Director,
QA Manufacturing Sites
Responsibility
-
-
-
-
-
-
Review this Global Policy
Ensure the Deployment / Implementation of this Global Policy
at applicable Global Apotex sites
Review this Global Policy
Asegurar la implementación / ejecución de esta Política Global dentro de las
funciones de cumplimiento Global.
Review this Global Policy
Supervisar la gestión, revisión, aprobación y despliegue /
implementación de esta Política Global en sitios de Apotex mundial
aplicables.
Emitir, examinar y revisar esta Política Global según la orientación y
regulación de la autoridad sanitaria actual.
Distribuir esta Política Global..
Coordinar la implementación / ejecución de esta Política Global en sitios de
Apotex mundial aplicables.
Despliegue de la ayuda / implementación de esta Política Global en sitios de
Apotex mundial aplicables.
Coordinar actividades de seguridad de la cadena de suministro a
través de equipos interdisciplinarios y departamentos en el sitio.
Asegúrese de que procesos de seguridad de la cadena de suministro se
definen, implementados y revisados, y que los recursos necesarios están
disponibles en el sitio.
Global Director,
Quality Compliance
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Global Director,
QA Policy & Systems
Global QA Policy & Systems
Department
-
-
-
Site Leadership Team
(Site Operations Head,
Site Quality Head)
-
-
-
8.0 Requerimientos Generales.
8.1 Entender el riesgo y la seguridad de la cadena de suministro.
8.1.1 Riesgo de adulteración (incluyendo económicamente motivado adulteración)
8.1.1.1 Adulteración puede ocurrir en muchas formas, incluyendo el producto que está contaminada,
insegura o fabricados en condiciones de no cumplir con buenas prácticas de manufactura, o
producto que no cumple con sus requisitos para la pureza y la fuerza, o no aprobadas para ser
comercializada en el país.
Apotex puede no ser capaz de prevenir completamente la falsificación a través de la Plaza del
mercado global. El objetivo es definir los controles adecuados para minimizar el riesgo de los
productos falsificados.
8.1.2 Riesgo de medicamentos falsificados.
8.1.2.1
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8.1.2.2. La falsificación puede aplicarse a productos tanto marcas y genéricos, y productos falsificados
pueden incluir productos con ingredientes correctos o incorrectos, con ingredientes activos
insuficientes o falta de ingredientes activos en conjunto, o con el empaquetado falso.
Apotex puede realizar evaluaciones de riesgos para ayudar a identificar los productos y
regiones presentan el mayor riesgo de falsificación. Esto puede usarse para ayudar a priorizar la
asignación de recursos contra la falsificación.
Desvío ilegal ocurre cuando un producto farmacéutico genuino es aprobado y destinado a la venta
en un país, pero es luego interceptado ilegalmente y vendido en otro país. Estos esquemas se
logran a menudo a través de declaraciones falsas o declaraciones. A veces, los reguladores de
medicamentos en el segundo país no han aprobado el uso de la droga desviado. Desvío ilegal
también puede ocurrir dentro de la misma área geográfica, o dentro del mismo país o ciudad. Este
tipo consiste en desviar medicamentos con descuento de un pretendido grupo de consumidores a
otro grupo de compra de medicamentos en un mercado abierto y no reglamentado.
Prevenir y detectar la desviación ilegal no pueden lograrse mediante una única organización.
Cada miembro de la cadena de suministro debe involucrarse en la prevención y detección del
desvío ilegal desarrollar un enfoque integral.
Gestión de riesgos de calidad (consulte GPOL-014) se utilizarán para conocer y comprender el
producto de la droga y para evaluar la probabilidad de que se desvíen. Factores de riesgo pueden
incluir productos de alto valor de drogas, medicamentos en corto la fuente, los productos con un
alto potencial para el abuso de drogas o productos que son ampliamente utilizados de la droga.
Entender la naturaleza de los riesgos de desviación ilegal es un elemento importante en el diseño
de un programa contra la desviación proactivo.
Entender los riesgos asociados con un producto robado es clave para la prevención.
Gestión del riesgo de robo de carga es similar a las claves asociadas al desvío ilegal.
¿Cómo y dónde está siendo transportado un producto de drogas son factores claves de
riesgo que debe ser entendidos.
Comprensión de Apotex de delincuencia local, sistema educativo y las condiciones políticas y
legales obstaculizan o incluso apoyando la falsificación, robo o desvío ilegal ayudará a identificar
zonas geográficas de riesgo para la seguridad.
Comprensión de estos riesgos puede utilizarse para aumentar el contenido de la
auditoría, actividades experimentales y controles.
Como parte de un enfoque de gestión de riesgos de calidad, las actividades de mitigación de
riesgo pueden incluir la aplicación de medidas más estrictas para medicamentos con alto riesgo
de falsificación, robo o desvío ilegal.
8.1.2.3
8.1.3. Riesgo de medicamentos desviados.
8.1.3.1.
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8.1.3.2
8.1.3.3
8.1.4. Riesgo de robo de carga.
8.1.4.1.
8.1.4.2
8.1.5. Identificación de riesgos de factores geográficos.
8.1.5.1.
8.1.5.2
8.1.6. Clasificación de riesgo y filtrado para distinguir las prácticas.
8.1.6.1.
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8.1.6.2 La evaluación del riesgo puede ser revisada para determinar si Apotex mantendrá operaciones
específicas para ayudar a evitar la falsificación, desvío ilegal o robo.
Buenas análisis son esenciales para garantizar la seguridad de los materiales suministrados y
detectar la adulteración, intencional o no intencional.
Apotex puede realizar una evaluación de riesgos de calidad de los procesos de fabricación e
identificar cualquier material potencialmente vulnerables..
Se entenderá las limitaciones de los métodos actuales, y donde se pueden desarrollar métodos de
prueba apropiados, físicas, químicas o biológicas para identificar el material. El fabricante es
responsable por la seguridad de todos los materiales utilizados en la fabricación y la utilización de
los análisis más apropiado..
8.1.7. Risk Mitigation – Analytical/Characterization
8.1.7.1.
8.1.7.2
8.1.7.3
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8.2. A manual, computerized, and/or enterprise-w ide inventory management system must be in place
w ith supervision from qualified personnel.
9.0 Quality Risk Management (QRM)
9.1 The QRM shall be used to develop a risk-based approach to supply chain security. This includes
assessing risks, developing controls, conducting risk review s, and communicating appropriately.
Refer to GPOL-014.
As part of the risk management process, processes shall be established to assure risks are
communicated throughout the organization. Refer to GPOL-002.
9.2
10.0 Manufacturing, Packaging, and Labeling Controls Program
10.1 In the context of a drug product, adulteration results in a drug w hich is not w hat it is purported to
be. Adulteration can be accidental or intentional. Additional controls are required to reduce the
risk of adulteration w hen there are complex supply chains w hich involve significant outsourcing of
manufacturing and distribution.
10.1.1 Refer to Section 8.0 (General Requirements) in considering potential and current
control measures in the manufacturing, packaging, and labelling of the drug products,
w ith a look at potential advancement in technology.
10.2 Further consideration shall be given to assessing established controls for packaging and labeling
systems and controls on returned and salvaged products. Procedures shall be established w hich
describe the destruction of packaging and labeling materials.
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10.3 Destruction of rejected materials should be accounted for and proof of the destruction shall be
obtained and documented. Accountability for the destruction of labels and packaging materials,
and destruction of returned products, shall extend to the management of third party suppliers,
contract manufacturers, and logistics service providers.
Also refer to GPOL-007 (Manufacturing, Packaging, and Labelling Controls) and GPOL-023
(Warehouse Controls).
10.4
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11.0 Material Controls
11.1
11.2
11.3
11.4
11.5
11.6
Both customers and inter-company receivers of a drug product shall be particularly careful to
monitor for the intrusion of diverted product.
Seal numbers taken off arriving trucks shall be checked against the seal numbers recorded on
shipping papers.
The number of boxes received shall be the same as the number of boxes recorded on the
shipping papers and invoices as shipped.
Boxes shall be examined for evidence of original closures (e.g. tape w hich may have been
replaced).
Boxes w ith visible differences (e.g. different shade or size of carton) shall be examined carefully.
Also refer to GPOL-012 (Material Controls).
12.0 Warehouse Controls and Distribution Controls
12.1 Detection processes shall be consistent w ith the risk of illegal diversions of given drug product.
Monitoring of packaging, packing, and shipping departments shall be review ed to determine if the
use of surveillance equipment is w arranted.
12.1.1
12.1.2
12.1.3
Workers in these areas should be aw are of the area surveillance as a deterrent.
Periodic job rotation, to include security personnel, should be considered.
The signal detection process shall involve:
-
-
-
Defining targets for enhanced, ongoing scrutiny
Applying environmental scanning to those targets (e.g. review ing external
information that may have an impact on the targets)
Determining the relevance of the results of environmental scans
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12.2 The identity of the person w ho packs from bulk and w ho packs for shipping shall be recorded.
Claims for shortages shall be checked for correlation to these w orkers. Product stolen by w orkers
is considered diverted product.
Processes shall be in place to verify the physical integrity of the container structure prior to
loading, including the reliability of the locking mechanisms of the doors.
Numbered single-use seals shall be used and recorded on shipping papers w hen the entire
conveyance is used for one shipment. Only designated employees shall distribute seals for
integrity purposes. There shall be procedures in place for the control and reconciliation of seals,
describing how to properly affix seals onto loaded containers and how to recognize and report
compromised seals or seal discrepancies.
Arriving cargo shall be reconciled against information on the cargo manifest. The cargo shall be
accurately described, and the w eights, labels, marks, and piece count indicated and verified.
Departing cargo shall be verified against purchase or delivery orders.
Drivers delivering or receiving cargo shall be positively identified before cargo is received or
released.
Customers shall be directed to return all unsold product to the manufacturer for evaluation.
Returned materials shall be dispositioned in accordance to approved w ritten procedures.
If the customer is in another country w here the return is not feasible, special care shall be taken
to arrange for destruction by a trusted third party organization.
12.3
12.4
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12.5
12.6
12.7
12.8
12.9
12.10 Returned product shall be analyzed to determine authenticity. If the product is not authentic,
Apotex shall investigate w here the potentially diverted or counterfeit product entered the supply
chain.
12.11 Also refer to GPOL-029 (Distribution Controls), GPOL-023 (Warehouse Controls), and
GSOP-029-001 (Shipping Under Quarantine).
13.0 Supplier Quality Management and Audit Program
13.1 The elements of the Supplier Quality Management Program shall be integrated to allow
appropriate modes of controls to be implemented. When these controls are integrated, there is a
higher level of assurance over suppliers and outsourced activities. Refer to GPOL-027 (Supplier
Qualification Program) and GPOL-015 (Audit Program).
Quality risk management principles (risk-based approach) utilized in the process of assessing
and selecting a potential supplier shall be applied appropriately to the material being supplied.
Communication of Apotex’s requirements and standards are to be clearly communicated at the
start of the assessment/selection process.
13.2
13.3
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13.4 A multi-disciplinary approach is highly recommended in the supplier selection process. Including
functional groups such as Regulatory, Quality, Safety, Health, and Environmental (SHE),
Technical, Security, and Procurement w ill frequently lead to a more balanced assessment of
potential suppliers. Similarly, having a cross functional team involved in the audit (e.g. a new
supplier) is part of the risk-based approach.
The full extent of the supply chain shall be know n and documented in a manner providing the
necessary visibility. Apotex shall have current understanding of information from second and third
tier suppliers on the logistics of supply chain from the origin of procured materials through to
receipt at the manufacturing location. Apotex shall also have current information from the site of
manufacture to the next legal ow ner or buyer of the product.
Apotex may not alw ays receive material directly from the original manufacturer, but rather through
a distributor/broker. In the assessment of a distributor/broker, it is important to understand
expectations w ith regard to supervision of the original manufacturer.
Once the selection process is complete, w ritten agreements for quality activities shall be
developed w ith the supplier of choice. Quality/Technical Agreements, Supply Agreements,
contracts, or comparable w ritten agreements shall clearly communicate and document Apotex’s
requirements and standards, and shall specify the need for the supplier to conform to the
agreements.
13.7.1 Minimum requirements shall be established around notification of changes, notification
of significant deviations, notification of any regulatory inspections, a provision for
documentation review , and a provision for on-site audits.
13.5
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13.6
13.7
13.8
13.9
Supplier performance shall be monitored and review ed on a regular basis.
A defined audit program shall be established w ith risk-based criteria for frequency and duration of
audits.
14.0 Logistics and Transportation Service Providers
14.1 The management of logistics and transportation service providers is analogous to Supplier
Quality Management in that the process for the assessment, selection, monitoring, and review
are similar; how ever, the focus includes more elements of security features.
Controls must be in place to assure logistic service providers do not become an avenue for illegal
diversion or introduction of counterfeit products into the supply chain.
Specific attention shall be applied to ensure pertinent security measures are in place and adhered
to at the logistics and/or transportation service provider.
As part of the selection and assessment, there shall be evidence of financial soundness,
capability of meeting contractual security requirements, and the ability to identify and correct
security deficiencies.
14.2
14.3
14.4
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11. GLOBAL POLICY
Division:
Title:
GLOBAL QUALITY
Page
11 of 12
Number
GPOL-038
Revision
0
SUPPLY CHAIN SECURITY – TAMPERING AND COUNTERFEIT CONTROLS
14.5 Background information, including a history of claims, the types of commodities handled, and the
geographical areas served shall be provided by the service provider and used as part of the
assessment and selection process. Hiring practices of the provider shall be review ed.
A review of the sales volume and relevant permits of the provider shall be review ed in
comparison to the size of the operation and authorization to handle pharmaceutical products,
w here such permits are required.
Review of physical premises, hiring practices, and access controls must be satisfactory in
meeting security measures.
14.6
14.7
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15.0 External References
Document Title
Health Products and Food Branch Inspectorate (HPFBI), Good
Manufacturing Practices (GMP), Guidelines - 2009 Edition, Version 2,
GUI-0001, March 4, 2011
(w ww.hc-sc.gc.ca)
Health Products and Food Branch Inspectorate (HPFBI), Policy on
Counterfeit Health Products, POL-0048, May 14, 2010
(w ww.hc-sc.gc.ca)
Food And Drug Administration, Inspections, Compliance, Enforcement,
and Criminal Investigations – Inspections – Investigations Operations
Manual, Sub-chapter 8.8 – Counterfeiting/Tampering
(w ww.fda.gov)
EudraLex, The Rules Governing Medicinal Products in the European
Union, EU Guidelines for Good Manufacturing Practice for Medicinal
Products for Human and Veterinary Use (Volume 4), 2008, Annex 20:
Quality Risk Management
(w ww.ec.europa.eu)
ICH Harmonised Tripartite Guideline, Quality Risk Management Q9,
Current Step 4 version, November 9, 2005
(w ww.ich.org)
Pharmaceutical Security Institute
Counterfeit Situation
w ww.psi-inc.org
World Health Organization
General information on counterfeit medicines
WHO Technical Report Series, No. 902, 2002, Annex 9, Guidelines on
Packaging for Pharmaceutical Products
(w ww.who.int)
WHO Guidance
Reference Type
Health Canada Guidance
Health Canada Policy
US FDA Manual
European Commission
Guidance
(EMEA,MHRA)
International Conference
on Harmonisation (ICH)
Guidance
PSI Guidance
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12. GLOBAL POLICY
Division:
Title:
GLOBAL QUALITY
Page
12 of 12
Number
GPOL-038
Revision
0
SUPPLY CHAIN SECURITY – TAMPERING AND COUNTERFEIT CONTROLS
16.0 Revision History
Revision Effective
No.Date
0 Current
Change
Control
No.
46061
Description / Reason for Change
New Global Policy “Supply Chain
Security – Tampering and Counterfeit
Controls”.
Author of
Revision
Elaine Leong,
Manager, QA SOD
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13. APPROVALS AND SIGNATURES
UserName: Jeremy Desai (apotexjdesai)
Title: President & C.O.O, Apotex Inc.
Date: Thursday, 23 May 2013, 12:23 PM Eastern Time
Meaning: Approval
================================================
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11:59:59
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UserName: Jila Breeze (apotexjbreeze)
Title: VP, Corporate Quality & Compliance
Date: Tuesday, 28 May 2013, 08:51 AM Eastern Time
Meaning: QA Approval
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