Marv Shepherd, PSM president, Member USP Package Storage and Distribution Expert Committee, and Professor at the University of Texas at Austin speaks about updates to United States Pharmacopeia's good distribution practices.
1. The document discusses Good Manufacturing Practices (GMP) guidelines for pharmaceutical manufacturing as outlined by various organizations like WHO, FDA, and the Government of India.
2. GMP guidelines ensure consistent high quality of medicines through defining standards for facilities, equipment, operations, documentation, personnel qualifications and training.
3. Adherence to GMP is important for the quality, safety and efficacy of pharmaceutical products and for exporting drugs to other countries that require meeting GMP standards.
PIC/S is an organization that was established to harmonize and improve Good Manufacturing Practice standards among member countries. It brings together regulatory authorities and pharmaceutical quality systems to ensure uniformity. PIC/S provides guidelines for industry, inspectors, and regulatory authorities to facilitate information sharing and mutual understanding, with the goal of protecting public health by helping to ensure the quality and safety of medical products globally.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
The International Council for Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss technical requirements for drug registration. ICH has produced guidelines on quality, safety, efficacy, and multidisciplinary topics. The quality guidelines cover stability testing, analytical validation, impurities, Good Manufacturing Practice, and quality risk management. Together, the ICH guidelines aim to harmonize technical requirements across regions to provide efficient drug development and approval.
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
The document discusses quality management systems in the pharmaceutical industry. It states that quality management systems (QMS) rely on regulations and guidelines to ensure effective quality control in pharmaceutical companies. The International Council for Harmonization (ICH) guideline provides a model for an effective QMS and is intended to assist manufacturers in maintaining quality and safety of their products and services. QMS is an important aspect of the pharmaceutical industry for regulating quality and safety.
This document summarizes a presentation on ICH Guideline Q9 on quality risk management. The objectives are to understand the concept of quality risk management, risk, and ICH Q9's role in new drug development. It discusses quality risk management as a systematic process to assess, control, communicate and review risks to drug quality across the product lifecycle. ICH Q9 provides principles and tools for quality risk management that can be applied at various stages including development, manufacturing, and distribution. It emphasizes linking quality risk management activities to protecting patient safety.
This document summarizes ICH Q8 guidelines on pharmaceutical development. It outlines the key components of drug development, including drug substances, excipients, formulation development, manufacturing process development, container closure systems, and compatibility studies. The objectives of Q8 are to design a quality product and manufacturing process using scientific approaches and quality risk management. It advocates moving from quality by testing to quality by design to build quality in from the beginning and continuously improve through the product lifecycle.
1. The document discusses Good Manufacturing Practices (GMP) guidelines for pharmaceutical manufacturing as outlined by various organizations like WHO, FDA, and the Government of India.
2. GMP guidelines ensure consistent high quality of medicines through defining standards for facilities, equipment, operations, documentation, personnel qualifications and training.
3. Adherence to GMP is important for the quality, safety and efficacy of pharmaceutical products and for exporting drugs to other countries that require meeting GMP standards.
PIC/S is an organization that was established to harmonize and improve Good Manufacturing Practice standards among member countries. It brings together regulatory authorities and pharmaceutical quality systems to ensure uniformity. PIC/S provides guidelines for industry, inspectors, and regulatory authorities to facilitate information sharing and mutual understanding, with the goal of protecting public health by helping to ensure the quality and safety of medical products globally.
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
The International Council for Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss technical requirements for drug registration. ICH has produced guidelines on quality, safety, efficacy, and multidisciplinary topics. The quality guidelines cover stability testing, analytical validation, impurities, Good Manufacturing Practice, and quality risk management. Together, the ICH guidelines aim to harmonize technical requirements across regions to provide efficient drug development and approval.
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
The document discusses quality management systems in the pharmaceutical industry. It states that quality management systems (QMS) rely on regulations and guidelines to ensure effective quality control in pharmaceutical companies. The International Council for Harmonization (ICH) guideline provides a model for an effective QMS and is intended to assist manufacturers in maintaining quality and safety of their products and services. QMS is an important aspect of the pharmaceutical industry for regulating quality and safety.
This document summarizes a presentation on ICH Guideline Q9 on quality risk management. The objectives are to understand the concept of quality risk management, risk, and ICH Q9's role in new drug development. It discusses quality risk management as a systematic process to assess, control, communicate and review risks to drug quality across the product lifecycle. ICH Q9 provides principles and tools for quality risk management that can be applied at various stages including development, manufacturing, and distribution. It emphasizes linking quality risk management activities to protecting patient safety.
This document summarizes ICH Q8 guidelines on pharmaceutical development. It outlines the key components of drug development, including drug substances, excipients, formulation development, manufacturing process development, container closure systems, and compatibility studies. The objectives of Q8 are to design a quality product and manufacturing process using scientific approaches and quality risk management. It advocates moving from quality by testing to quality by design to build quality in from the beginning and continuously improve through the product lifecycle.
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.
Who good distributionpracticesforpharmaceuticalproductsadeelzia84
The document summarizes the history and contents of the WHO Good Distribution Practices for Pharmaceutical Products guidelines. It was originally adopted in 2005 and revised in 2009 to improve security against counterfeit medicines. The goals are to ensure quality and identity of pharmaceuticals during distribution. It defines distribution and outlines general principles like traceability and responsibilities across the supply chain. Key points covered include regulations, personnel training, documentation, repackaging, recalls, investigating counterfeits, and next steps to finalize the guidelines.
This document discusses organizational structures for pharmaceutical quality assurance. It states that the heads of production and quality control must be independent of each other according to EU GMP guidelines. It also lists the typical educational backgrounds needed for various roles in pharmaceutical production, quality assurance/quality control, and management. Finally, it provides a flow chart illustrating the process flow from receiving to shipping in a pharmaceutical manufacturing facility.
The document discusses Good Manufacturing Practices (GMP) guidelines according to ICH Q7A. It states that both GMP and cGMP aim to prevent bad quality products from entering the market. GMP applies to pharmaceutical and healthcare products, while cGMP refers to using the most up-to-date production processes and technologies to comply with regulations, as defined by the FDA. Regulatory agencies that establish GMP standards are mentioned, along with the objectives of GMP and specific guidelines covering quality management, personnel, facilities, equipment, documentation, and production records.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
This document discusses Good Manufacturing Practices (GMP) for pharmaceuticals. It introduces GMP, explaining that GMP ensures pharmaceutical products are consistently manufactured and controlled to quality standards for their intended use. It also discusses the relationships between quality assurance (QA), GMP, and quality control (QC), explaining that QA oversees the whole system, GMP is the quality system for manufacturing, and QC tests samples of products. Current good manufacturing practices (cGMP) are also introduced as the GMP regulations enforced by the FDA to control manufacturing operations and assure drug identity, strength, quality and purity.
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
The document discusses Good Laboratory Practices (GLP). It provides definitions and history of GLP. GLP refers to a quality management system for laboratories conducting non-clinical safety studies. It aims to ensure reliability and integrity of test data. Key aspects of GLP include organization, SOPs, facilities, equipment, test systems, study planning and reporting, archiving. Non-compliance can result in disqualification and rejection of study data by regulatory agencies.
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.
The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.
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.
The document discusses current Good Manufacturing Practices (cGMP) regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It provides an overview of key topics including:
- What cGMPs are and why they are important to assure drug quality and purity.
- Where cGMP regulations come from, including the Federal Food, Drug, and Cosmetic Act and sections in the Code of Federal Regulations (CFR) that pertain specifically to drug and device cGMPs.
- Some examples of cGMP requirements the FDA evaluates, such as those related to quality control responsibilities and personnel qualifications, as well as examples of evidence manufacturers can provide to demonstrate compliance.
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.
Documentation in Pharmaceutical IndustryPratik Parikh
The document discusses documentation requirements in the pharmaceutical industry. It outlines key documents like standard operating procedures, master formula records, batch manufacturing records, and specifications and test procedures that are necessary for quality assurance. Documentation provides evidence of manufacturing and testing activities, ensures clarity of communication, and helps improve quality and attain regulatory certifications. Proper documentation is essential for compliance with good manufacturing practices.
GLP (Good Laboratory Practice) is a quality system for non-clinical health and environmental safety studies. It was instituted in the US after fraudulent data was submitted by toxicology labs. GLP aims to ensure studies are properly planned, monitored, and reported, and that data accurately reflects results. It promotes international acceptance of safety tests. The OECD principles provide an international standard for GLP, covering topics like facility organization, test system and item characterization, and record keeping. India has established a National GLP Compliance Monitoring Authority to oversee GLP standards.
This document provides an overview of Good Distribution Practices (GDP) for pharmaceutical products. It discusses that GDP aims to ensure quality and identity of pharmaceuticals during distribution by establishing adequate controls over handling, storage and distribution. It outlines key requirements for GDP certification including personnel training, documentation, storage and transportation procedures to prevent issues like contamination or mixing of products. Obtaining GDP certification demonstrates a company's commitment to quality and safety standards across its entire pharmaceutical supply chain.
Good Manufacturing Practices (GMP) ensure consistency in the quality of pharmaceutical products. GMP guidelines cover quality control, documentation, personnel qualifications, premises, equipment, materials, production, and quality assurance. Adherence to GMP is important for pharmaceutical export and most regulatory agencies only approve imports of medicines made under GMP standards. Key aspects of GMP include qualification and validation of equipment and processes, complaint handling, recalls, and self-inspections. GMP guidelines also exist specifically for herbal medicines to ensure quality, safety and efficacy of these complex biological products.
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
[Infographic] A One Page Guide to Global GDP GuidelinesPharma IQ
http://www.coldchainiq.com/regulatory-resources/white-papers/a-one-page-guide-to-global-gdp-guidelines/
All GDP guidelines in one single place!
Good Distribution Practice (GDP) is the part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification. There is no single global GDP standard. Cold Chain IQ has created this easy to-assimilate summary of GDP requirements around the world, enabling you to navigate the landscape. You can keep it as a handy reference, share it around your colleagues or even stick it on your wall!
Leading Practices for Distribution SuccessNet at Work
This document summarizes a 1 hour webinar about NetSuite presented by Angela Davis and Laurence Donoghue of NetAtWork. The webinar covered NetSuite's financial management, marketing, and order management capabilities for wholesale distribution. It also reviewed NetSuite's subscription model and implementation approach, including a 100 day implementation process with training, configuration, testing, and go-live support. Attendees were invited to ask questions during the webinar.
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.
Who good distributionpracticesforpharmaceuticalproductsadeelzia84
The document summarizes the history and contents of the WHO Good Distribution Practices for Pharmaceutical Products guidelines. It was originally adopted in 2005 and revised in 2009 to improve security against counterfeit medicines. The goals are to ensure quality and identity of pharmaceuticals during distribution. It defines distribution and outlines general principles like traceability and responsibilities across the supply chain. Key points covered include regulations, personnel training, documentation, repackaging, recalls, investigating counterfeits, and next steps to finalize the guidelines.
This document discusses organizational structures for pharmaceutical quality assurance. It states that the heads of production and quality control must be independent of each other according to EU GMP guidelines. It also lists the typical educational backgrounds needed for various roles in pharmaceutical production, quality assurance/quality control, and management. Finally, it provides a flow chart illustrating the process flow from receiving to shipping in a pharmaceutical manufacturing facility.
The document discusses Good Manufacturing Practices (GMP) guidelines according to ICH Q7A. It states that both GMP and cGMP aim to prevent bad quality products from entering the market. GMP applies to pharmaceutical and healthcare products, while cGMP refers to using the most up-to-date production processes and technologies to comply with regulations, as defined by the FDA. Regulatory agencies that establish GMP standards are mentioned, along with the objectives of GMP and specific guidelines covering quality management, personnel, facilities, equipment, documentation, and production records.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
This document discusses Good Manufacturing Practices (GMP) for pharmaceuticals. It introduces GMP, explaining that GMP ensures pharmaceutical products are consistently manufactured and controlled to quality standards for their intended use. It also discusses the relationships between quality assurance (QA), GMP, and quality control (QC), explaining that QA oversees the whole system, GMP is the quality system for manufacturing, and QC tests samples of products. Current good manufacturing practices (cGMP) are also introduced as the GMP regulations enforced by the FDA to control manufacturing operations and assure drug identity, strength, quality and purity.
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
The document discusses Good Laboratory Practices (GLP). It provides definitions and history of GLP. GLP refers to a quality management system for laboratories conducting non-clinical safety studies. It aims to ensure reliability and integrity of test data. Key aspects of GLP include organization, SOPs, facilities, equipment, test systems, study planning and reporting, archiving. Non-compliance can result in disqualification and rejection of study data by regulatory agencies.
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.
The Center for Drug Evaluation and Research (CDER) is responsible for protecting and promoting public health by ensuring the safety and effectiveness of human drugs. CDER oversees new drug development and reviews marketing applications, monitors drug safety after approval, and ensures quality in manufacturing. CDER's mission is to ensure that drugs are safe and effective for their intended use through activities like reviewing new drug applications, communicating drug information to health professionals and consumers, and facilitating innovation in drug development.
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.
The document discusses current Good Manufacturing Practices (cGMP) regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It provides an overview of key topics including:
- What cGMPs are and why they are important to assure drug quality and purity.
- Where cGMP regulations come from, including the Federal Food, Drug, and Cosmetic Act and sections in the Code of Federal Regulations (CFR) that pertain specifically to drug and device cGMPs.
- Some examples of cGMP requirements the FDA evaluates, such as those related to quality control responsibilities and personnel qualifications, as well as examples of evidence manufacturers can provide to demonstrate compliance.
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.
Documentation in Pharmaceutical IndustryPratik Parikh
The document discusses documentation requirements in the pharmaceutical industry. It outlines key documents like standard operating procedures, master formula records, batch manufacturing records, and specifications and test procedures that are necessary for quality assurance. Documentation provides evidence of manufacturing and testing activities, ensures clarity of communication, and helps improve quality and attain regulatory certifications. Proper documentation is essential for compliance with good manufacturing practices.
GLP (Good Laboratory Practice) is a quality system for non-clinical health and environmental safety studies. It was instituted in the US after fraudulent data was submitted by toxicology labs. GLP aims to ensure studies are properly planned, monitored, and reported, and that data accurately reflects results. It promotes international acceptance of safety tests. The OECD principles provide an international standard for GLP, covering topics like facility organization, test system and item characterization, and record keeping. India has established a National GLP Compliance Monitoring Authority to oversee GLP standards.
This document provides an overview of Good Distribution Practices (GDP) for pharmaceutical products. It discusses that GDP aims to ensure quality and identity of pharmaceuticals during distribution by establishing adequate controls over handling, storage and distribution. It outlines key requirements for GDP certification including personnel training, documentation, storage and transportation procedures to prevent issues like contamination or mixing of products. Obtaining GDP certification demonstrates a company's commitment to quality and safety standards across its entire pharmaceutical supply chain.
Good Manufacturing Practices (GMP) ensure consistency in the quality of pharmaceutical products. GMP guidelines cover quality control, documentation, personnel qualifications, premises, equipment, materials, production, and quality assurance. Adherence to GMP is important for pharmaceutical export and most regulatory agencies only approve imports of medicines made under GMP standards. Key aspects of GMP include qualification and validation of equipment and processes, complaint handling, recalls, and self-inspections. GMP guidelines also exist specifically for herbal medicines to ensure quality, safety and efficacy of these complex biological products.
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
[Infographic] A One Page Guide to Global GDP GuidelinesPharma IQ
http://www.coldchainiq.com/regulatory-resources/white-papers/a-one-page-guide-to-global-gdp-guidelines/
All GDP guidelines in one single place!
Good Distribution Practice (GDP) is the part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification. There is no single global GDP standard. Cold Chain IQ has created this easy to-assimilate summary of GDP requirements around the world, enabling you to navigate the landscape. You can keep it as a handy reference, share it around your colleagues or even stick it on your wall!
Leading Practices for Distribution SuccessNet at Work
This document summarizes a 1 hour webinar about NetSuite presented by Angela Davis and Laurence Donoghue of NetAtWork. The webinar covered NetSuite's financial management, marketing, and order management capabilities for wholesale distribution. It also reviewed NetSuite's subscription model and implementation approach, including a 100 day implementation process with training, configuration, testing, and go-live support. Attendees were invited to ask questions during the webinar.
Css 2013 temperature controlled transport - risk mitigation - luc huybreght...Pauwels Consulting
This document discusses temperature controlled transport according to EU GDP regulations. It provides an overview of GDP requirements and emphasizes the importance of quality control and integrity across the entire supply chain. It then outlines a risk mitigation approach for temperature controlled transport, including mapping processes, assessing risks, and developing control strategies based on probability and severity scores. The goal is to guarantee quality from manufacturer to patient.
Susan M. Smith Assistant: Jennifer L. Jones
Tel: 410-247-2500, x204 Tel: 410-247-2500, x205
Email: ssmith@biostorage.net Email: jjones@biostorage.net
Laboratory Director: Repository Manager:
Dr. John P. Williams Michael J. Wilson
Tel: 410-247-2500, x206 Tel: 410-247-2500, x207
Email: jwilliams@biostorage.net Email: mwilson@biostorage.net
Quality Assurance Manager: IT Manager:
Lisa A. Johnson, PhD Thomas E. Brown
Tel: 410
The purpose of Gap Analysis is to assist pharmaceutical manufacturers, distributors or 3 PLs (3rd Party Logistics Providers) to help them identify gaps in their cold chain supply chain network or systems.
What you will learn:
* The regulatory aspects related to the cold chain
* Responsibilities in the supply chain
* Requirements for the storage and handling of drug products
* Packaging, transportation and distribution of drug products
* Performing a gap analysis to know what needs to be done in order to fully comply with regulations and optimize your processes
* Ways and means to develop an executable action plan
How you will benefit:
* Understand how to execute a cold chain regulatory gap analysis
* Discover what should be covered when looking at cold chain compliance
* Gap analysis: The first step to develop a cold chain compliance program
* Uncover the requirements for the storage and distribution of drug products
* Sharing the responsibilities for a good cold chain compliance
BioStorage is an off-site biospecimen storage facility that adheres to industry best practices like ISBER guidelines. It has over 5600 square feet of space with 24/7 monitoring and backup systems. BioStorage offers biological specimen management, transportation, lab equipment maintenance, freezer sales, and contract research services like cell culture and antibody production.
This document discusses best practices for building Drupal distributions. It recommends including responsive themes, faceted search, batteries included functionality, and demo content. It also addresses challenges like maintaining interoperable features, default configurations, and sustainability. Customizing the installation process, improving the admin experience, and using panels are also suggested to create a better distribution.
This document provides an overview of supply chain transportation management. It discusses key concepts like the functions of transportation management, factors in selecting transportation modes, and strategies for fleet sizing and routing/scheduling. Transportation is described as a fundamental part of logistics that aims to move goods efficiently at a cost of 5-6% of product price on average. The document also briefly outlines emerging areas like multimodal transportation and how technology is shaping the future of transportation.
This document provides guidelines on good distribution practices for biological products in India. It outlines general principles for maintaining quality throughout the distribution chain from manufacturer to patient. Key points include:
- Establishing an organizational structure and quality system for all entities involved in storage and distribution. This includes training personnel, implementing standard operating procedures, and conducting self-inspections.
- Ensuring suitable premises, equipment, vehicles and environmental conditions for storage and transportation in compliance with product and regulatory requirements. Critical factors like temperature, humidity and cleanliness must be controlled.
- Maintaining appropriate documentation systems to allow for traceability of products and support recalls or returns if needed. Deviations from storage/transport conditions should be investigated and corrective actions
GLP (Good Laboratory Practice) is a quality system concerned with conducting non-clinical safety studies. It aims to ensure studies are accurately reported and not fraudulent. GLP has principles for organization, personnel, facilities, test systems, operating procedures, performance and reporting of studies. India's National GLP Compliance Monitoring Authority monitors adherence. GLP compliance certification is required for safety studies of products like pesticides, pharmaceuticals and food additives, and helps protect human and environmental health while facilitating international trade.
TGA Presentation: Biologicals framework updatesTGA Australia
The document summarizes recent changes and proposed updates to Australia's regulatory framework for biological products such as human cells and tissues (biologicals). Key points:
- The biologicals framework regulates cell and tissue therapies and was introduced in 2011. It applies different regulation levels based on product risks.
- Recent approvals include various tissue-based products and cell therapies. Challenges include improving product characterization and developing potency assays.
- Proposed changes include updating guidance documents, expanding expedited pathways similar to the US and EU, and allowing some autologous cell/tissue uses to be exempt from regulation.
- The review aims to facilitate earlier patient access to innovative therapies while maintaining safety, efficacy and
This presentation introduces pharmaceutical quality assurance and quality control. It discusses that quality assurance covers all aspects of production from raw materials to finished products. Quality control ensures drugs are safe, effective and consistent. The presentation covers in-process quality control, production processes like blending and milling, and quality control of the storage facility. It also discusses technology transfer requirements for pharmaceutical production like manufacturing instructions, analytical methods and batch records.
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Regulatory affairs professionals ensure that pharmaceutical products comply with regulations throughout the development, manufacturing, and marketing processes. They advise internal departments and collect data to submit to regulatory agencies for approvals. Dossiers containing technical documents are submitted for registration. Modules cover administrative information, quality overview, chemistry and manufacturing controls for drug substances and products, preclinical data, and clinical trial results. Regulatory professionals help companies avoid issues by properly managing records, data, and agency requirements.
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. These slides provide an overview of current regulations, with a focus on pharmaceuticals and healthcare.
Global regulatory agencies are pushing for comprehensive cold chain monitoring programs that extend from raw materials to distribution to patients. Proper validation and qualification of storage facilities has become necessary to demonstrate compliance with good manufacturing practices. Sensitech provides a variety of validation services including installation, operational, and performance qualification to ensure storage environments consistently meet acceptance criteria and protect product quality throughout the supply chain.
EMS - Environmental Management Introduction Training Presentation.pdfInnocent Bhaikwa
This document provides an overview of environmental management. It defines an environmental management system and lists its key elements. It describes tools for environmental management like environmental impact assessments and life cycle assessments. It outlines relevant environmental legislation. It explains that an environmental management system documents policies, processes, and controls to create environmentally friendly products and meet requirements. The document lists benefits of environmental management systems and guidelines for implementation, including establishing objectives and involving management.
Therapeutics Goods Administration(TGA) is a unit of the Australian Government Department of Health and Ageing, is responsible for administering the act.
Presentation Recall of Therapeutic Goods – Overview TGA Australia
This document provides an overview of recalls of therapeutic goods in Australia. It discusses the roles and responsibilities of different parties in coordinating and conducting recalls, including the Recalls Section of the Australian Department of Health, sponsors, manufacturers, and the Therapeutic Goods Administration (TGA). Key points covered include:
- The Uniform Recall Procedure for Therapeutic Goods (URPTG) provides definitions and procedures for different types of recalls and non-recall actions.
- Manufacturers, sponsors and the TGA each have responsibilities in identifying issues, assessing risks, developing communication strategies, and reporting on recall outcomes.
- The TGA reviews recall plans, publishes information on the System of Australian Recall Actions (SARA) database,
GOOD LABORATORY PRACTICE by ILyas Mphil student.pptxAtaUrRahman50751
This document discusses Good Laboratory Practice (GLP) guidelines. It was prepared by Ilyas Ahamd and Siyar Khan, who are M.Phil scholars. GLP provides a framework for planning, conducting, monitoring, recording, reporting and archiving laboratory studies to ensure the safety of users, consumers and the environment. Key aspects of GLP include qualified personnel, validated equipment and methods, standard operating procedures, accurate documentation and record keeping, quality assurance programs, and facility organization and management. GLP aims to ensure data integrity and that results submitted to regulatory agencies accurately reflect what was found in studies.
The document discusses the International Council for Harmonization (ICH), which brings together regulatory authorities and the pharmaceutical industry to discuss technical requirements for drug development and approval. The ICH aims to harmonize these requirements between countries to prevent redundant testing and facilitate drug approval. It provides over 70 guidelines on quality, safety, efficacy and other topics that are implemented by regulatory agencies. Stability testing guidelines help establish a product's shelf life by evaluating how its qualities change over time under different storage conditions.
The document discusses the International Council for Harmonization (ICH), which brings together regulatory authorities and the pharmaceutical industry to discuss technical requirements for drug development and approval. The ICH aims to harmonize these requirements across regions to increase efficiency and reduce duplication. It develops guidelines on quality, safety, efficacy and other areas that are implemented by regulatory agencies. Over 70 guidelines have been produced covering topics like stability testing, clinical trials and good manufacturing practices. The document provides details on the ICH organization, guideline development process, and some examples of quality guidelines.
The document provides an overview of regulatory affairs. It discusses the historical development of regulation, including key events that led to increased regulation of drugs and medical products. It also outlines the roles and responsibilities of regulatory affairs departments and professionals in submitting information and ensuring compliance with regulations from agencies like the FDA to obtain approval to market products. The goal of regulatory affairs is to protect public health by ensuring safety, efficacy and quality of drugs and other medical products.
Presentation investing-in-medical-device-safetyTGA Australia
The document discusses the importance of having a functional Quality Management System (QMS) for medical device companies. It notes that over 5000 medical device incident reports are filed each year, with most incidents being rooted in quality system deficiencies. The Therapeutic Goods Administration (TGA) regulates medical devices in Australia and may get involved when investigations into incidents find insufficient clarity or corrective actions from companies. A case study highlights how the TGA intervened when a company failed to adequately address increased failure rates in a patient monitoring device. The key takeaway is that companies should invest in quality control processes and actively maintain their QMS to avoid safety issues.
Similar to PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribution Practices Update (20)
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This document discusses why importing prescription drugs from Canada is not a viable solution to high drug costs in the US. It notes that previous state-level importation programs failed due to lack of savings and inability to adequately regulate foreign pharmacies. Proper testing of imported drugs is very expensive and would consume any savings. There are also safety concerns, as importation would undermine track-and-trace systems and Canada's drug supply is already limited. Law enforcement experts warn that importation could exacerbate the opioid crisis and organized crime may exploit regulatory loopholes. The document argues policymakers should focus on real solutions rather than unrealistic importation proposals.
In this webinar I provide an overview of counterfeits in America, I talk about some myths of importation, and I teach patients and patient advocates some great tips for saving money safely.
In this presentation, Director of National Outreach Shabbir Imber Safdar reviews the current state of counterfeit drugs in America today, discusses some of the myths surrounding importation, and provides tips for saving money safely on the cost of prescription drugs.
This document discusses the threats posed by counterfeit medicines. It provides several examples of counterfeit medicines breaching the US supply chain and being distributed through "Canadian" websites and social media sites. The counterfeits have been found to contain no active ingredients, toxic ingredients, or incorrect doses of active ingredients. They are manufactured under unsafe conditions but can appear virtually indistinguishable from real medicines. The document emphasizes that counterfeit medicines pose a real threat to patient health and safety.
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2. PSM China's members include associations representing pharmaceutical manufacturers, distributors, hospitals, and licensed pharmacists.
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
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Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
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PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribution Practices Update
1. United States Pharmacopeia
Good Distribution Practices Update
Marv Shepherd, Ph.D.
President
Partnership for Safe Medicines
Member
USP Package Storage and Distribution Expert Committee
Professor, University of Texas at Austin
Email: marvshepherd@austin.utexas.edu
2. Mission of United States Pharmacopeia
} “To improve the health
of people around the
world through public
standards and related
programs that help
ensure the quality,
safety and benefits of
medicines and foods.”
*
3. Purpose of USP
} 130 countries use USP standards
} USP-NF (National Formulary) contains
the specifications, storage, packaging
and other requirements. “Specifications”
are lists of series of specific tests and
acceptance criteria of drug substances or
excipients.
} USP-NF is the “official U.S. Drug
Compendium.”
*
4. Agenda
} Introduction
} Overview of Packaging Storage and Distribution
Committee (PSD) Expert Committee (EC)
} Goals of the PSD Expert Committee
} Processes of the Committee
} Reorganization of Good Distribution Practices
Chapter (1083)
*
6. Package, Storage and Distribution Expert Committee
Members
– USP Liaison: Desmond Hunt (USP)
– Govt Agencies: Sarah Skuce (Health Canada), FDA Liaisons: Don
Klein,
– Academia: Marv Shepherd (University of Texas)
– Industry Mfging: Shirley Feld (Sanofi), Dennis Jenke (Baxter), Dan
Malinowski (Pfizer), Dan Norwood (Boehringer Ingelheim), Kola
Stucker (BMS)
– Industry Consultants: Dana Guazzo (Rx Pax), Kevin O’Donnell
(Exelsus Cold Chain Management), Devinder Pal (Catalyst Pharma),
Mike Ruberto Material Needs Consulting), Chris Chandler (GS1 US);
– Industry Suppliers: Diane Paskiet (West)
– Chair: Mary Foster (Foster Group)
– Vice-Chair: Michael Eakins (Eakins and Associates)
*
7. Goals of the Packaging Storage and
Distribution Expert Committee
1. Developing and updating USP standards for packaging
systems and their materials of construction (metal, glass,
plastic, elastomeric).
2. Revising packaging definitions including storage
requirements for compendial articles.
3. Creating and revising guidance for the good distribution of
compendial articles; good packaging & repackaging
practices; extractable and leachable.
*
8. Working Process
– Subcommittees – within the Expert Committee(s)
– Expert Panels – external partner working teams
– Workshops
– Education programs; webinars
– Conclaves – experts from all facets discussion
– Bi-monthly telecoms; annual meetings
– Charter
– Minutes
– Action Items
*
9. UPS 2013 “Pain in the Chain”
Healthcare Survey
} UPS conducts an global annual survey of
healthcare suppliers to get their perceptions on the
concerns/issues in distributing health care
products, including pharmaceuticals. In 2013, they
surveyed 440 health care companies. The results
corresponds closely with the initiatives of the USP.
} http://www.ups.com/content/us/en/bussol/browse/industries/
pain-in-the-chain.html
*
10. *
2013 UPS Survey
Please note:
Product security ranked
higher than managing
supply chain cost in 2013
11. *
2013 UPS Survey Found
US/W EU - regulatory compliance
• Asia Pacific - product security
12. } Process: General Chapters (GC), Review/Revise
every 3 years
} Actions, this cycle:
– The two General Chapters on Good Distribution Practices
are being reviewed by two Expert Committees (EC)
• Package Storage Distribution EC review <1079> Good Distribution
Practices for Drug Products; Revision official Dec 1, 2012, [USP 35
(2)]
• Excipients EC: <1197> Good Distribution Practices For Bulk
Pharmaceutical Excipients; New chapter, official May 1, 2013
*
Current Process, Actions & Outcomes
13. Outcomes of this cycle:
– Significant: Collaboration with 4 Expert Committees:
1) Packaging, Storage and Distribution EC
2) Excipients EC
3) Dietary Supplements EC
4) Compounding EC
– Significant
– Proposed change is to have one overarching Good
Distribution Practices General Chapter <1083>
– With ‘sub-chapter’ structure: Good Distribution for Drugs
<1079> & Good Distribution for Excipients <1197> become
sub-chapters of chapter <1083>
1) 4 sub-chapters completed and 5 sub-chapters in writing
*
14. Current Process, Actions & Highlights
Chapter Structure
GDP Subjects Divided into Sub-Chapters
<1083>
<1083.1> <1083.2> <1083.3> <1083.4>
Significant:
• Pharmacopeia Forum 40 (2) Mar-Apr 2014; comments in from May 31, 2014
being edited now by Expert Committee
• Sub-chapter process – 4 form foundation; 5 started; next subjects up for
consideration
8
15. Significant Scope Changes
Scope: Applies to all
organizations & individuals
involved in any aspect ...
GC’s
<1079>
<1197>
Intended: drugs & excipients
… NOT Intended for
•API’s, Medical devices; gases
•Radioactive products, reagents &
Solvents
•CTM- no storage requirement
… NOT Intended To Cover,
•Counterfeiting; falsified medicine,
pedigrees, supply chain security, chain
of custody
Scope: Applies to all
GC
<1083>
organizations
& individuals involved with
packaging materials & product
regardless of their category…
Intended: drug products & excipients
Also, Intended for,
•API’s, Medical devices; combination
products, Radioactive products, reagents
& Solvents
Added: Dietary supplements; biological &
biotechnological; cell & gene therapy
… Intended To Cover,
•Counterfeiting; falsified medicine
•Traceability SC integrity, Cargo thefts,
Diversion
10
PLEASE NOTE: Applies to all organizations not just
traditional manufacturers, wholesalers, exporters
importers, etc.
It covers: Hospital to hospital, wholesaler or supplier
to pharmacy, mail order pharmacy to patient,
pharmacy to pharmacy, pharmacy to health care
facilities (i.e. long-term-care facility).
16. *
<1083>
Good Distribution Practices
USP General Chapter <1083>
Good Distribution Practices
Sub-Chapter <1083.1>
Quality Management System
(QMS)
<1083.1> <1083.2> <1083.3> <1083.4>
11
17. Significant: Quality Management System
(QMS)
Responsibilities
* Applicant holder, OTC (no
application) & repackager
GC’s
<1079>
<1197>
• QMS – 4 Management Systems
(MS)
1.Storage MS
2.Distribution MS
3.Environmental MS
4.Risk MS
• Refrigerators & freezers (not covered
yet in new work)
• Labeling (depth not covered yet in new
work)
Responsibilities
GC
<1083>
• * Senior management (all SC
partners)
• QMS – 8 Standard practices, more
depth
• Management responsibility
• Documentation
• Resources management
• Operations
• Complaints, deviations, returns,
recalls, counterfeits, reprocessing,
rework
• Monitoring & improvements
• Validation
• Regulatory affairs
12
18. Significant: Why not just use cGMPs & GDPs
from regulators or other sources?
} USP must cover all stakeholders
•May seem redundant to a few, but needed by smaller
companies, virtual firms or new business entities
•Compendial Standard – as such is translated into multiple
languages; not every country has a standard QMS
expectation
•Does not supersede or supplant national requirements
*
Quality Management System
19. *
USP General Chapter <1083>
Good Distribution Practices
Sub-Chapter <1083.2>
Environmental Control Management
<1083.1> <1083.2> <1083.3> <1083.4>
15
20. Environmental Conditions
Management
Temperature
* Monitoring
* Mapping
* MKT during storage
GC’s
<1079>
<1197>
Disribution Temp data loggers
•Significant: not covered
yet in new chapter
Mail delivery distribution not
covered yet in new chapter
Environmental Control 2
Approaches:
GC
<1083>
1) Facilities, Equipment, Vehicles
2) Using packaging materials – thermal
blankets, temp stabilizers, light
Significarnets: iCstoanntitn mgeantceyr ipallasn, dfoers oicuctaagnetss,
breakdowns
•Monitor each shipment with retrospective
historical data & risk assessment to justify
shipping method
•Data monitoring: evaluation; communication
• Significant: Short term excursions:
Combine stability data from long-term
& accelerated studies, temp studies
16
21. *
USP General Chapter <1083>
Good Distribution Practices
Sub-Chapter <1083.3>
Importation & Exportation Management
<1083.1> <1083.2> <1083.3> <1083.4>
18
22. Importation & Exportation
Management
<1079> No discussion
<1197> Covers
Audits, container seals,
GC’s
<1079>
<1197>
cargo inspection, customs,
brokers, trade rules, product
verification
• <1197> knowing product &
applicable regulatory requirements
• Supply agreements
Intended to cover I/E process:
1. Business-to-business – all
GC
<1083>
stakeholders (suppliers, brokers,
customers, …)
2. Business-to-government – customs
clearance, documentation, port
authorities
Knowledge of product & material
•Likelihood of theft, abuse,
counterfeiting, diversion.
•Contractual agreements to ensure
security
Not intended to cover:
•Importation & Exportation law
•Customs procedures (country specific)
19
26. GOOD DISTRIBUTION PRACTICES
<1083>
Introduction
QUALITY
MANAGEMENT
SYSTEM
<1083.1>
ENVIRONMENTAL
CONDITIONS
MANAGEMENT
<1083.2>
IMPORTATION &
EXPORTATION
MANAGEMENT
<1083.3>
SUPPLY CHAIN
INTEGRITY &
SECURITY
<1083.4>
Finished Drug
Products
<1083.5>
Excipients
<1083.6>
Clinical Trial
Materials
<1083.9>
Active
Pharmaceutical
Ingredients
<1083.7>
Packaging
Components &
Materials
<1083.8>
• Bringing in new support, experts in each field for panels, suppliers
• Forming Expert Panels now! 26
27. Closing
Regulatory Compliance: No one regulatory authority/
organization can secure the supply chain
–Prevention through strengthened regulatory capacity and
tight supply chains (partnerships)
–Entity-to-Entity visibility & collaboration
– A collective response when substandard & counterfeit
products are found
– Product Security: Protection & Damage
Early and rapid detection of suspicious products
Solutions for security and damage
27
28. Join the Challenge !
} Submit an application to serve as an USP expert volunteer
} Apply for current cycle’s Expert Panels
} What other subjects would be of value as GDP Sub-
Chapters?
} Questions?
} Visit the USP web site at www.usp.org
} Contact USP at USPVolunteers@usp.org or
301-816-8151
28
29. Thanks
A special thanks goes to Dr. Mary Foster,
Chair USP Packaging Storage and
Distribution Expert Committee. She was
extremely helpful to me in putting this
presentation together.