Phụ lục 17 về kiểm tra chất lượng cung ứng theo tham số chuẩn trong tiêu chuẩn GMP EU. Xem thêm các tài liệu khác trên kênh của Công ty cổ phần Tư vấn Thiết kế GMP EU
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.
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), noting that QA oversees the whole system, GMP ensures consistent manufacturing quality, and QC tests samples to ensure quality. Finally, it provides an overview of key aspects of GMP, including facilities, equipment, packaging, and documentation.
GMP and cGMP considerations ensure consistent manufacturing and quality control of pharmaceutical products. Key points:
1. GMP aims to minimize risks like contamination or incorrect dosing that cannot be eliminated through final testing.
2. QA, GMP and QC are interrelated but distinct - QA ensures overall quality, GMP covers all production aspects, and QC involves sampling, testing and release procedures.
3. Following GMP guidelines is important for safety, efficacy and export opportunities. GMP requires documented procedures covering all steps to build quality into every batch.
This document outlines requirements for a Hazard Analysis and Critical Control Point (HACCP)-based food safety system. It references legislation requiring food businesses to implement HACCP principles. It also references Codex Alimentarius guidelines on applying HACCP and establishing prerequisite programs. The requirements are intended to help certifying bodies assess food businesses' compliance with HACCP systems and help businesses develop such systems. The requirements cover areas like management responsibility, product and process information, prerequisite programs, hazard analysis, control measures, and documentation.
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.
Phụ lục 17 về kiểm tra chất lượng cung ứng theo tham số chuẩn trong tiêu chuẩn GMP EU. Xem thêm các tài liệu khác trên kênh của Công ty cổ phần Tư vấn Thiết kế GMP EU
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.
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), noting that QA oversees the whole system, GMP ensures consistent manufacturing quality, and QC tests samples to ensure quality. Finally, it provides an overview of key aspects of GMP, including facilities, equipment, packaging, and documentation.
GMP and cGMP considerations ensure consistent manufacturing and quality control of pharmaceutical products. Key points:
1. GMP aims to minimize risks like contamination or incorrect dosing that cannot be eliminated through final testing.
2. QA, GMP and QC are interrelated but distinct - QA ensures overall quality, GMP covers all production aspects, and QC involves sampling, testing and release procedures.
3. Following GMP guidelines is important for safety, efficacy and export opportunities. GMP requires documented procedures covering all steps to build quality into every batch.
This document outlines requirements for a Hazard Analysis and Critical Control Point (HACCP)-based food safety system. It references legislation requiring food businesses to implement HACCP principles. It also references Codex Alimentarius guidelines on applying HACCP and establishing prerequisite programs. The requirements are intended to help certifying bodies assess food businesses' compliance with HACCP systems and help businesses develop such systems. The requirements cover areas like management responsibility, product and process information, prerequisite programs, hazard analysis, control measures, and documentation.
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 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.
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.
This document provides guidance for assessing the comparability of biotechnological products before and after changes to the manufacturing process. It aims to assist manufacturers in collecting relevant technical information to demonstrate that manufacturing changes will not adversely impact quality, safety or efficacy. The guidelines cover analytical techniques, characterization, specifications, stability and other quality, nonclinical and clinical considerations for evaluating comparability. The goal is to ensure the quality, safety and efficacy of products produced by changed processes through evaluating relevant data. A finding of comparability does not require identical quality attributes but highly similar attributes without adverse impacts on safety or efficacy.
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.
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical
Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its
manufacturing process. It is first produced for the original marketing application and
can be updated to support new knowledge gained over the lifecycle of a product. The
Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
This document provides an overview of key elements and basic principles of Good Manufacturing Practices (GMP). It defines GMP and cGMP, outlines their importance in ensuring product quality and safety, and describes characteristics of GMP-compliant products. The document also summarizes key elements of GMP like personnel, premises, equipment, materials, and quality control. It emphasizes the importance of documentation, validation, recalls, self-inspection, storage and training in adhering to GMP. The objectives of GMP and guidelines from various regulatory bodies are also briefly mentioned.
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.
The document discusses the International Council for Harmonization (ICH) and its goal of improving efficiency in drug development and registration. It provides an overview of the ICH's phases and agreement to continue harmonization efforts. The rest of the document focuses on Quality by Design (QbD), including defining the pharmaceutical development process, quality systems, quality risk management, and moving from empirical to systematic and knowledge-driven approaches. It provides details on the contents and topics that should be included in pharmaceutical development submissions to regulatory agencies.
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.
GMP in Pharmaceutical Industry by Dr.A S CharanCharan Archakam
The document provides an overview of Good Manufacturing Practices (GMP) guidelines from various regulatory bodies around the world such as the US FDA, WHO, EU, and India. It discusses the history and development of GMP guidelines and regulations. It also summarizes some key GMP guidelines including the US FDA's 21 CFR Parts 210 and 211, WHO's GMP guidelines, ICH Q7 guidelines for APIs, and India's Schedule M under the Drugs and Cosmetics Act. The document further highlights some historical incidents due to lack of GMP compliance and the importance of following GMP guidelines.
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.
Phụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩm. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
Sai pharma solutions inc scientific-regulatory affairs-qms and c gmp consult...JRamniwas
This document provides an overview of consulting services offered by Sai Pharma Solutions Inc. related to quality management, regulatory affairs, and GMP compliance for pharmaceutical industries. The company's vision is to help clients achieve global regulatory compliance through education, training, auditing, and documentation services. Key services include GAP analyses, audits and checklists, SOP development, regulatory submissions, technical support, and online consultations. The goal is to help clients obtain regulatory approval by ensuring their facilities, equipment, methods, and personnel meet all necessary qualifications and standards.
International Conference on Harmonisation (ICH) was created in 1990
Agreement between the EU, Japan, and the USA to harmonize different regional requirements for registration of pharmaceutical drug products.
The document provides an overview of ISO 22000, an international food safety management standard. It describes key aspects of ISO 22000 such as its emphasis on controlling food safety hazards along the entire food chain. It also summarizes several sections of the ISO 22000 standard which establish requirements for food safety management systems, including documentation, management responsibility, and resource management.
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
This document provides a guideline for an effective pharmaceutical quality system across the product lifecycle. It describes a model quality system that achieves product quality objectives, establishes process control, and facilitates continual improvement. Key elements include management commitment, quality planning, resource management, communication, and management reviews. Quality risk management and knowledge management are important enablers. The quality system extends to outsourced activities and materials. Implementation of this guideline will help companies strengthen the link between development and manufacturing to enhance quality and availability of medicines.
This document provides an overview of ICH Q10, which describes a pharmaceutical quality system model based on ISO quality concepts and GMP regulations. The quality system can be implemented throughout a product's lifecycle to facilitate innovation, continual improvement, and strengthen the link between development and manufacturing. ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities to achieve product realization, establish state of control, and facilitate continual improvement.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
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.
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.
This document provides guidance for assessing the comparability of biotechnological products before and after changes to the manufacturing process. It aims to assist manufacturers in collecting relevant technical information to demonstrate that manufacturing changes will not adversely impact quality, safety or efficacy. The guidelines cover analytical techniques, characterization, specifications, stability and other quality, nonclinical and clinical considerations for evaluating comparability. The goal is to ensure the quality, safety and efficacy of products produced by changed processes through evaluating relevant data. A finding of comparability does not require identical quality attributes but highly similar attributes without adverse impacts on safety or efficacy.
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.
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical
Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its
manufacturing process. It is first produced for the original marketing application and
can be updated to support new knowledge gained over the lifecycle of a product. The
Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
This document provides an overview of key elements and basic principles of Good Manufacturing Practices (GMP). It defines GMP and cGMP, outlines their importance in ensuring product quality and safety, and describes characteristics of GMP-compliant products. The document also summarizes key elements of GMP like personnel, premises, equipment, materials, and quality control. It emphasizes the importance of documentation, validation, recalls, self-inspection, storage and training in adhering to GMP. The objectives of GMP and guidelines from various regulatory bodies are also briefly mentioned.
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.
The document discusses the International Council for Harmonization (ICH) and its goal of improving efficiency in drug development and registration. It provides an overview of the ICH's phases and agreement to continue harmonization efforts. The rest of the document focuses on Quality by Design (QbD), including defining the pharmaceutical development process, quality systems, quality risk management, and moving from empirical to systematic and knowledge-driven approaches. It provides details on the contents and topics that should be included in pharmaceutical development submissions to regulatory agencies.
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.
GMP in Pharmaceutical Industry by Dr.A S CharanCharan Archakam
The document provides an overview of Good Manufacturing Practices (GMP) guidelines from various regulatory bodies around the world such as the US FDA, WHO, EU, and India. It discusses the history and development of GMP guidelines and regulations. It also summarizes some key GMP guidelines including the US FDA's 21 CFR Parts 210 and 211, WHO's GMP guidelines, ICH Q7 guidelines for APIs, and India's Schedule M under the Drugs and Cosmetics Act. The document further highlights some historical incidents due to lack of GMP compliance and the importance of following GMP guidelines.
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.
Phụ lục 7. Hướng dẫn của WHO trong chuyển giao công nghệ sản xuất dược phẩm. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU.
Sai pharma solutions inc scientific-regulatory affairs-qms and c gmp consult...JRamniwas
This document provides an overview of consulting services offered by Sai Pharma Solutions Inc. related to quality management, regulatory affairs, and GMP compliance for pharmaceutical industries. The company's vision is to help clients achieve global regulatory compliance through education, training, auditing, and documentation services. Key services include GAP analyses, audits and checklists, SOP development, regulatory submissions, technical support, and online consultations. The goal is to help clients obtain regulatory approval by ensuring their facilities, equipment, methods, and personnel meet all necessary qualifications and standards.
International Conference on Harmonisation (ICH) was created in 1990
Agreement between the EU, Japan, and the USA to harmonize different regional requirements for registration of pharmaceutical drug products.
The document provides an overview of ISO 22000, an international food safety management standard. It describes key aspects of ISO 22000 such as its emphasis on controlling food safety hazards along the entire food chain. It also summarizes several sections of the ISO 22000 standard which establish requirements for food safety management systems, including documentation, management responsibility, and resource management.
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
This document provides a guideline for an effective pharmaceutical quality system across the product lifecycle. It describes a model quality system that achieves product quality objectives, establishes process control, and facilitates continual improvement. Key elements include management commitment, quality planning, resource management, communication, and management reviews. Quality risk management and knowledge management are important enablers. The quality system extends to outsourced activities and materials. Implementation of this guideline will help companies strengthen the link between development and manufacturing to enhance quality and availability of medicines.
This document provides an overview of ICH Q10, which describes a pharmaceutical quality system model based on ISO quality concepts and GMP regulations. The quality system can be implemented throughout a product's lifecycle to facilitate innovation, continual improvement, and strengthen the link between development and manufacturing. ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities to achieve product realization, establish state of control, and facilitate continual improvement.
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
ICH Q10/WHO TRS provides a regulatory perspective on quality guidelines. It discusses the history of WHO GMP guidelines and introduces ICH Q10, which describes a pharmaceutical quality system to ensure product quality over the lifecycle. ICH Q10 complements GMPs and facilitates continual improvement. It has been adopted by various regulatory agencies and provides a comprehensive approach to quality management.
The document summarizes the ICH Q10 guideline, which provides a framework for pharmaceutical quality systems throughout the lifecycle of pharmaceutical products. The guideline aims to facilitate continual improvement and quality risk management. It augments good manufacturing practices and covers topics like management responsibility, process performance monitoring, change management, and knowledge management. When combined with ICH Q8 on pharmaceutical development and ICH Q9 on quality risk management, ICH Q10 provides a harmonized approach to ensuring product quality.
This document provides guidance for the Pharmaceutical Development section of regulatory submissions for drug products. It describes the objective to provide a comprehensive understanding of the product and manufacturing process. Key aspects addressed include: components of the drug product; formulation, manufacturing process, container closure, and control strategy development; use of quality risk management; establishment of a design space; and submission organization. The degree of regulatory flexibility is based on the level of scientific knowledge provided regarding pharmaceutical and manufacturing sciences.
This document provides an overview and summary of ICH Q10, which describes a model quality management system for the pharmaceutical industry. The objectives of ICH Q10 are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. It applies throughout the product lifecycle and augments regional GMP requirements. Key elements include process performance and product quality monitoring, corrective and preventive action systems, change management, management review, knowledge management, and quality metrics.
The document provides an overview of ICH Q10 guidelines and knowledge management. It discusses key aspects of ICH such as objectives to harmonize technical requirements for drug registration. It also summarizes some of the main ICH quality guidelines such as Q7, Q8, Q9 and Q10. The document then focuses on explaining ICH Q10 which describes a pharmaceutical quality system model. It discusses elements of the quality system like process and product monitoring, CAPA, change management and management review. Finally, the document discusses two enablers of the quality system as per ICH Q10 - knowledge management and quality risk management. It provides a brief introduction to knowledge management and its importance in the pharmaceutical industry.
GMP and cGMP considerations were discussed in the document. Some key points include:
- GMP refers to good manufacturing practices that help ensure 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, where safety and efficacy are integral parts of quality.
- A basic tenet of GMP is that quality must be built into each batch during manufacturing rather than tested into the final product. This helps minimize risks that cannot be eliminated through final testing.
- GMP covers all aspects of production from facilities and equipment to staff training and hygiene. Detailed written procedures are essential.
The document provides guidelines on pharmaceutical development as described in ICH Q8(R2). It discusses the objective to design a quality product and manufacturing process. Key points covered include critical quality attributes, design space, control strategies, flexibility opportunities, and examples of QbD application. The annex to ICH Q8(R1) further explains quality by design principles and their application in practice.
Pmtc good cleaning validation practiceRamy Mostafa
The document provides an overview of regulatory guidance and best practices for cleaning validation in the pharmaceutical industry. It discusses the origins of commonly used acceptance limits for cleaning validation of 0.001 dose and 10 ppm. It also outlines a lifecycle approach to cleaning validation involving stages of process design, process qualification through testing, and continued process verification. Automated and manual cleaning methods are described along with considerations for each.
ICH Q10 defines a pharmaceutical quality system based on ISO quality concepts and GMP regulations. It is a model for managing quality throughout a product's lifecycle. The objectives are to achieve product realization, establish a state of control, and facilitate continual improvement. Key elements include monitoring processes, corrective actions, change management, and management reviews. Senior management is responsible for ensuring an effective quality system is in place and resources are provided to achieve quality objectives. The system should be continually improved based on monitoring, assessments, and management reviews.
ICH Q10 GUIDELINES (PHARMACEUTICAL QUALITY SYSTEM)
- Contents
- ICH
- ICH GUIDELINES
- Objective
Q10 GUIDELINE
- Introduction
- Scope
- Objective of Q10 Guideline
- Elements
- CAPA System
- Change Management System
- Continual improvement of pharmaceutical quality system
- References
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The document summarizes ICH Q10, which provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes the contents and sections of ICH Q10, including management responsibility, continual improvement of process performance and product quality, and continual improvement of the pharmaceutical quality system. The goal is to establish an effective quality management system for the pharmaceutical industry and enhance the quality and availability of medicines.
This document presents an overview of the Pharmaceutical Quality Systems (ICH Q10) guideline. ICH Q10 establishes a quality management system model for the pharmaceutical industry and was intended to help companies comply with Good Manufacturing Practices. The objectives of ICH Q10 are to achieve product realization, establish control, and facilitate continual improvement. ICH Q10 also discusses management responsibility, risk management, challenges of implementing the new system, and the relationship between ICH Q10 and other quality standards like GMP.
quality by design in pharmaceutical development ICH Q8 guidelinessSUJITHA MARY
The document provides an overview of ICH Q8 guidelines for quality by design (QbD) in pharmaceutical development. It discusses key aspects of the QbD framework including defining critical quality attributes and critical process parameters. The guidelines aim to enhance product and process understanding using a science- and risk-based approach. This allows for greater control and consistency in manufacturing. The document also outlines regulatory and industry perspectives, as well as examples of applying QbD and modeling techniques scientifically.
This document provides guidance on quality risk management for the pharmaceutical industry. It outlines principles of quality risk management including responsibilities, risk assessment, risk control, risk communication, and risk review. The goal is to offer a systematic approach to quality risk management that supports existing quality practices and regulations. Quality risk management can help pharmaceutical companies and regulators make more effective risk-based decisions regarding drug quality across the product lifecycle. It is intended to complement, not replace, current regulatory requirements and quality systems.
Similar to Hệ thống chất lượng dược phẩm GMP EU (20)
This document provides guidance on good manufacturing practices for medicinal products. It discusses the importance of a pharmaceutical quality system to ensure that manufactured medicines are fit for use and comply with regulatory standards. Key elements of the quality system include good manufacturing practices, quality control, product quality reviews, and quality risk management. The quality system requires participation across all departments and levels of the company to ensure product safety, quality and efficacy.
This document discusses key aspects of designing pharmaceutical manufacturing facilities according to current Good Manufacturing Practices (cGMP). It covers process design tools like block flow diagrams, process flow diagrams, and piping and instrumentation diagrams that are used to design the facility layout and process flows. The document also discusses various unit operations in solid dosage manufacturing like material handling, milling, blending, compression, and coating. Facility design must meet regulatory requirements to facilitate operations, control materials, and prevent contamination according to cGMP.
This document lists various prequalified active pharmaceutical ingredients from the WHO. It includes the product ID, INN, grade, therapeutic area, applicant, date of prequalification, and confirmation date. There are over 400 entries listed with information about different APIs that have been prequalified for treatments of conditions like HIV/AIDS, malaria, tuberculosis, hepatitis, and others.
Danh mục 37 thuốc sản xuất trong nước được cấp giấy phép lưu hành tại Việt Nam - Đợt 185.
Quyết định được Cục Quản lý Dược Việt Nam ban hành vào tháng 7 năm 2023.
Danh mục 259 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 185.
Danh mục được ban hành bới Cục Quản lý Dược Việt Nam tháng 7 năm 2023.
Ngày 21/06 vừa qua, cục Quản lý Dược vừa ban hành quyết định về việc công bố danh mục thuốc biệt dược gốc - đợt 2 năm 2023.
Ban hành kèm theo quyết định này bao gồm 83 thuốc biệt dược gốc.
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP-EU.
Hướng dẫn thực hành này cung cấp thông tin cho các nhà sản xuất thức ăn có chất sát khuẩn không an toàn do thuốc chuyển sang thức ăn chăn nuôi không chứa thuốc hoặc một loại thức ăn khác. Mục đích của hướng dẫn này:
• “Sản xuất và phân phối thức ăn có chứa thuốc” đề cập đến việc sử dụng thiết bị để sản xuất, chế biến, đóng gói, giữ và phân phối thức ăn.
• “Thức ăn chăn nuôi” được sản xuất có thêm hóa chất bảo quản. Thức ăn cho động vật như vậy có thể được gọi trong hướng dẫn này là “thức ăn có tẩm thuốc” hoặc “thức ăn không có tẩm thuốc”, tùy thuộc vào việc thức ăn đó có được pha chế để chứa một loại thuốc mới dành cho động vật hay không. Để thuận tiện, chúng tôi gọi những loại thuốc mới dành cho động vật này đơn giản là “thuốc”.
• “Thuốc mang theo” đề cập đến sự hiện diện của thuốc trong lô thức ăn chăn nuôi tiếp theo.
• “Ô nhiễm không an toàn”: đề cập đến mức độ nhiễm bẩn, do một loại thuốc được phép sử dụng trong thức ăn chăn nuôi, gây ra rủi ro không thể chấp nhận được đối với sức khỏe con người hoặc động vật.
Nói chung, các tài liệu hướng dẫn của FDA không thiết lập các trách nhiệm có thể thực thi về mặt pháp lý. Thay vào đó nó mô tả Cơ quan về một chủ đề và chỉ nên được xem dưới dạng khuyến nghị, trừ khi các yêu cầu pháp lý hoặc quy định cụ thể được trích dẫn. Việc sử dụng từ nên trong hướng dẫn của Cơ quan có nghĩa là điều gì đó được gợi ý hoặc khuyến nghị, nhưng không bắt buộc.
Xem thêm các tài liệu khác trên trang của công ty cổ phần tư vấn thiết kể GMP EU.
Cục Quản lý Thực phẩm và Dược phẩm Hoa Kỳ đưa ra hướng dẫn cho các nhà sản xuất và phân phối sữa cho trẻ sơ sinh về các yêu cầu ghi nhãn nhất định đối với các sản phẩm này. Hướng dẫn này đặc biệt chú trọng đến số lượng các công thức sữa cho trẻ sơ sinh có bao bì tương tự nhưng khác nhau về thành phần hoặc mục đích sử dụng. Ngày càng nhiều các sản phẩm ghi sai nhãn về hàm lượng chất dinh dưỡng, do vậy hướng dẫn này cung cấp thông tin có thể giúp các nhà sản xuất hiểu và tuân thủ các yêu cầu ghi nhãn liên quan.
Hướng dẫn này không bao gồm đầy đủ tất cả các quy định liên quan đến việc ghi nhãn sữa công thức dành cho trẻ sơ sinh. Vì vậy bạn có thể xem thêm các hướng dẫn khác tại www.fda.gov/FoodGuidances hoặc các tài liệu trên kênh của công ty cổ phần tư vấn thiết kế GMP EU.
Ngày 25/05 vừa qua, Cục quản lý Dược vừa ban hành danh mục 69 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184.
Theo đó, ban hành kèm theo Quyết định này danh mục 69 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184, cụ thể:
1. Danh mục 64 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam hiệu lực 05 năm (Phụ lục I kèm theo).
2. Danh mục 05 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam hiệu lực 03 năm (Phụ lục II kèm theo).
Xem thêm các tài liệu khác trên trang của công tư cổ phần tư vấn thiết kế GMP EU.
Ngày 25/05 vừa qua, Cục quản lý Dược đã ban hành quyết định số 352/QĐ-QLD về việc ban hành danh mục 231 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 184.
Theo đề nghị của Trưởng phòng Đăng ký thuốc, Cục Quản lý Dược quyết định:
Ban hành kèm theo Quyết định này danh mục 231 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184, cụ thể:
1. Danh mục 172 thuốc sản xuất trong nước được gia hạn giấy đăng ký lưu hành hiệu lực 05 năm (Phụ lục I kèm theo).
2. Danh mục 52 thuốc sản xuất trong nước được gia hạn giấy đăng ký lưu hành hiệu lực 03 năm (Phụ lục II kèm theo).
3. Danh mục 07 thuốc sản xuất trong nước được gia hạn đăng ký lưu hành đến 31/12/2025 (Phụ lục III kèm theo).
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP EU.
Ngày 26/05 vừa qua, Cục Quản lý Dược đã ban hành quyết định số 371/QĐ-QLD về việc công bố danh mục thuốc biệt dược gốc Đợt 1 - năm 2023.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục Quản lý Dược, quyết định:
Công bố Danh mục 56 thuốc Biệt dược gốc Đợt 1 - Năm 2023 tại Phụ lục kèm theo Quyết định này.
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP EU.
Ngày 26/05 vừa qua, Cục Quản lý Dược vừa ra quyết định số 370/QĐ-QLD về việc ban hành danh mục 50 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 111 bổ sung.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục Quản lý Dược quyết định:
Ban hành kèm theo Quyết định này danh mục 50 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 111 bổ sung, bao gồm:
1. Danh mục 41 thuốc nước ngoài được cấp giấy đăng ký lưu hành hiệu lực 05 năm - Đợt 111 bổ sung (tại Phụ lục I kèm theo).
2. Danh mục 01 thuốc nước ngoài được cấp giấy đăng ký lưu hành hiệu lực 03 năm - Đợt 111 bổ sung (tại Phụ lục II kèm theo).
3. Danh mục 07 thuốc nước ngoài được gia hạn giấy đăng ký lưu hành hiệu lực 05 năm - Đợt 111 bổ sung (tại Phụ lục III kèm theo).
4. Danh mục 01 thuốc nước ngoài được gia hạn giấy đăng ký lưu hành đến 31/12/2025 - Đợt 111 bổ sung (tại Phụ lục IV kèm theo).
Ngày 24/05 vừa qua, Bộ Y tế vừa ban hành quyết định về việc công bố danh mục thuốc có chứng minh tương đương sinh học đợt 2 - năm 2023.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục quản lý Dược, quyết định:
Công bố Danh mục 28 thuốc có chứng minh tương đương sinh học Đợt 2 - Năm 2023 tại Phụ lục kèm theo Quyết định này.
Xem thêm các tài liệu khác của Công ty cổ phần Tư vấn thiết kế GMP EU.
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1. September 2015
EMA/CHMP/ICH/214732/2007
Committee for Human Medicinal Products
ICH guideline Q10 on pharmaceutical quality system
Step 5
Transmission to CHMP May 2007
Transmission to interested parties May 2007
Deadline for comments November 2007
Final adoption by CHMP June 2008
Date for coming into effect June 2008
3. IC H guideline Q10 on pharmaceutical quality system
EM A/CHMP/ICH/214732/2007 P age 2/20
Document History
Code History Date
Q10 Approval by the Steering Committee under Step 2 and release for
public consultation.
9 May
2007
Current Step 4 version
Q10 Approval by the Steering Committee under Step 4 and
recommendation for adoption to the three ICH regulatory bodies.
4 June
2008
Link to: ICH Q8/Q9/Q10 Training material
Link to: ICH Q8/Q9/Q10 Points to consider
4. IC H guideline Q10 on pharmaceutical quality system
EM A/CHMP/ICH/214732/2007 P age 3/20
ICH guideline Q10 on pharmaceutical quality system
Table of contents
1. Pharmaceutical quality system ................................................................... 4
1.1. Introduction .................................................................................................... 4
1.2. Scope............................................................................................................. 4
1.3. Relationship of ICH Q10 to regional GMP requirements, ISO standards and ICH Q7 ...... 5
1.4. Relationship of ICH Q10 to regulatory approaches .................................................. 5
1.5. ICH Q10 objectives........................................................................................... 5
1.6. Enablers: knowledge management and quality risk management .............................. 6
1.7. Design and content considerations....................................................................... 6
1.8. Quality manual ................................................................................................ 7
2. Management responsibility ......................................................................... 7
2.1. Management commitment.................................................................................. 7
2.2. Quality policy................................................................................................... 8
2.3. Quality planning ............................................................................................... 8
2.4. Resource management ...................................................................................... 8
2.5. Internal communication..................................................................................... 9
2.6. Management review.......................................................................................... 9
2.7. Management of outsourced activities and purchased materials ................................. 9
2.8. Management of change in product ownership ........................................................ 9
3. Continual improvement of process performance and product quality .... 10
3.1. Lifecycle stage goals ....................................................................................... 10
3.2. Pharmaceutical quality system elements............................................................. 10
4. Continual improvement of the pharmaceutical quality system............... 14
4.1. Management review of the pharmaceutical quality system..................................... 14
4.2. Monitoring of internal and external factors impacting the pharmaceutical quality system
.............................................................................................................................. 15
4.3. Outcomes of management review and monitoring ................................................ 15
5. Glossary...................................................................................................... 16
Annex 1........................................................................................................... 19
Annex 2........................................................................................................... 20
5. IC H guideline Q10 on pharmaceutical quality system
EM A/CHMP/ICH/214732/2007 P age 4/20
1. Pharmaceutical quality system
1.1. Introduction
This document establishes a new ICH tripartite guideline describing a model for an effective quality
management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality
System. Throughout this guideline, the term “pharmaceutical quality system” refers to the ICH Q10
model.
ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is
based on International Standards Organisation (ISO) quality concepts, includes applicable Good
Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and
ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can
be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10
applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not
intended to create any new expectations beyond current regulatory requirements. Consequently, the
content of ICH Q10 that is additional to current regional GMP requirements is optional.
ICH Q10 demonstrates industry and regulatory authorities’ support of an effective pharmaceutical
quality system to enhance the quality and availability of medicines around the world in the interest of
public health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation
and continual improvement and strengthen the link between pharmaceutical development and
manufacturing activities.
1.2. Scope
This guideline applies to the systems supporting the development and manufacture of pharmaceutical
drug substances (i.e., API) and drug products, including biotechnology and biological products,
throughout the product lifecycle.
The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each
of the product lifecycle stages, recognising the differences among, and the different goals of each
stage (see Section 3).
For the purposes of this guideline, the product lifecycle includes the following technical activities for
new and existing products:
Pharmaceutical Development:
Drug substance development;
Formulation development (including container/closure system);
Manufacture of investigational products;
Delivery system development (where relevant);
Manufacturing process development and scale-up;
Analytical method development.
Technology Transfer:
New product transfers during Development through Manufacturing;
Transfers within or between manufacturing and testing sites for marketed products.
6. IC H guideline Q10 on pharmaceutical quality system
EM A/CHMP/ICH/214732/2007 P age 5/20
Commercial Manufacturing:
Acquisition and control of materials;
Provision of facilities, utilities, and equipment;
Production (including packaging and labelling);
Quality control and assurance;
Release;
Storage;
Distribution (excluding wholesaler activities).
Product Discontinuation:
Retention of documentation;
Sample retention;
Continued product assessment and reporting.
1.3. Relationship of ICH Q10 to regional GMP requirements, ISO standards
and ICH Q7
Regional GMP requirements, the ICH Q7 Guideline, “Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients”, and ISO quality management system guidelines form the foundation for
ICH Q10. To meet the objectives described below, ICH Q10 augments GMPs by describing specific
quality system elements and management responsibilities. ICH Q10 provides a harmonised model for a
pharmaceutical quality system throughout the lifecycle of a product and is intended to be used
together with regional GMP requirements.
The regional GMPs do not explicitly address all stages of the product lifecycle (e.g., Development). The
quality system elements and management responsibilities described in this guideline are intended to
encourage the use of science and risk based approaches at each lifecycle stage, thereby promoting
continual improvement across the entire product lifecycle.
1.4. Relationship of ICH Q10 to regulatory approaches
Regulatory approaches for a specific product or manufacturing facility should be commensurate with
the level of product and process understanding, the results of quality risk management, and the
effectiveness of the pharmaceutical quality system. When implemented, the effectiveness of the
pharmaceutical quality system can normally be evaluated during a regulatory inspection at the
manufacturing site. Potential opportunities to enhance science and risk based regulatory approaches
are identified in Annex 1. Regulatory processes will be determined by region.
1.5. ICH Q10 objectives
Implementation of the Q10 model should result in achievement of three main objectives which
complement or enhance regional GMP requirements.
7. IC H guideline Q10 on pharmaceutical quality system
EM A/CHMP/ICH/214732/2007 P age 6/20
1.5.1. Achieve product realisation
To establish, implement and maintain a system that allows the delivery of products with the quality
attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities
(including compliance with approved regulatory filings) and other internal and external customers.
1.5.2. Establish and maintain a state of control
To develop and use effective monitoring and control systems for process performance and product
quality, thereby providing assurance of continued suitability and capability of processes. Quality risk
management can be useful in identifying the monitoring and control systems.
1.5.3. Facilitate continual improvement
To identify and implement appropriate product quality improvements, process improvements,
variability reduction, innovations and pharmaceutical quality system enhancements, thereby increasing
the ability to fulfil quality needs consistently. Quality risk management can be useful for identifying and
prioritising areas for continual improvement.
1.6. Enablers: knowledge management and quality risk management
Use of knowledge management and quality risk management will enable a company to implement ICH
Q10 effectively and successfully. These enablers will facilitate achievement of the objectives described
in Section 1.5 above by providing the means for science and risk based decisions related to product
quality.
1.6.1. Knowledge management
Product and process knowledge should be managed from development through the commercial life of
the product up to and including product discontinuation. For example, development activities using
scientific approaches provide knowledge for product and process understanding. Knowledge
management is a systematic approach to acquiring, analysing, storing and disseminating information
related to products, manufacturing processes and components. Sources of knowledge include, but are
not limited to prior knowledge (public domain or internally documented); pharmaceutical development
studies; technology transfer activities; process validation studies over the product lifecycle;
manufacturing experience; innovation; continual improvement; and change management activities.
1.6.2. Quality risk management
Quality risk management is integral to an effective pharmaceutical quality system. It can provide a
proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It
facilitates continual improvement of process performance and product quality throughout the product
lifecycle. ICH Q9 provides principles and examples of tools for quality risk management that can be
applied to different aspects of pharmaceutical quality.
1.7. Design and content considerations
a) The design, organisation and documentation of the pharmaceutical quality system should be well
structured and clear to facilitate common understanding and consistent application.
8. IC H guideline Q10 on pharmaceutical quality system
EM A/CHMP/ICH/214732/2007 P age 7/20
b) The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to
each of the product lifecycle stages, recognising the different goals and knowledge available for
each stage.
c) The size and complexity of the company’s activities should be taken into consideration when
developing a new pharmaceutical quality system or modifying an existing one. The design of the
pharmaceutical quality system should incorporate appropriate risk management principles. While
some aspects of the pharmaceutical quality system can be company-wide and others site-specific,
the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level.
d) The pharmaceutical quality system should include appropriate processes, resources and
responsibilities to provide assurance of the quality of outsourced activities and purchased materials
as described in Section 2.7.
e) Management responsibilities, as described in Section 2, should be identified within the
pharmaceutical quality system.
f) The pharmaceutical quality system should include the following elements, as described in Section
3: process performance and product quality monitoring, corrective and preventive action, change
management and management review.
g) Performance indicators, as described in Section 4, should be identified and used to monitor the
effectiveness of processes within the pharmaceutical quality system.
1.8. Quality manual
A Quality Manual or equivalent documentation approach should be established and should contain the
description of the pharmaceutical quality system. The description should include:
a) The quality policy (see Section 2);
b) The scope of the pharmaceutical quality system;
c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages
and interdependencies. Process maps and flow charts can be useful tools to facilitate depicting
pharmaceutical quality system processes in a visual manner;
d) Management responsibilities within the pharmaceutical quality system (see Section 2).
2. Management responsibility
Leadership is essential to establish and maintain a company-wide commitment to quality and for the
performance of the pharmaceutical quality system.
2.1. Management commitment
a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality
system is in place to achieve the quality objectives, and that roles, responsibilities, and authorities
are defined, communicated and implemented throughout the company.
b) Management should:
1) Participate in the design, implementation, monitoring and maintenance of an effective
pharmaceutical quality system;
9. IC H guideline Q10 on pharmaceutical quality system
EM A/CHMP/ICH/214732/2007 P age 8/20
2) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its
implementation throughout their organisation;
3) Ensure a timely and effective communication and escalation process exists to raise quality
issues to the appropriate levels of management;
4) Define individual and collective roles, responsibilities, authorities and inter-relationships of all
organisational units related to the pharmaceutical quality system. Ensure these interactions are
communicated and understood at all levels of the organisation. An independent quality
unit/structure with authority to fulfil certain pharmaceutical quality system responsibilities is
required by regional regulations;
5) Conduct management reviews of process performance and product quality and of the
pharmaceutical quality system;
6) Advocate continual improvement;
7) Commit appropriate resources.
2.2. Quality policy
a) Senior management should establish a quality policy that describes the overall intentions and
direction of the company related to quality.
b) The quality policy should include an expectation to comply with applicable regulatory requirements
and should facilitate continual improvement of the pharmaceutical quality system.
c) The quality policy should be communicated to and understood by personnel at all levels in the
company.
d) The quality policy should be reviewed periodically for continuing effectiveness.
2.3. Quality planning
a) Senior management should ensure the quality objectives needed to implement the quality policy
are defined and communicated.
b) Quality objectives should be supported by all relevant levels of the company.
c) Quality objectives should align with the company’s strategies and be consistent with the quality
policy.
d) Management should provide the appropriate resources and training to achieve the quality
objectives.
e) Performance indicators that measure progress against quality objectives should be established,
monitored, communicated regularly and acted upon as appropriate as described in Section 4.1 of
this document.
2.4. Resource management
a) Management should determine and provide adequate and appropriate resources (human, financial,
materials, facilities and equipment) to implement and maintain the pharmaceutical quality system
and continually improve its effectiveness.
10. IC H guideline Q10 on pharmaceutical quality system
EM A/CHMP/ICH/214732/2007 P age 9/20
b) Management should ensure that resources are appropriately applied to a specific product, process
or site.
2.5. Internal communication
a) Management should ensure appropriate communication processes are established and
implemented within the organisation.
b) Communications processes should ensure the flow of appropriate information between all levels of
the company.
c) Communication processes should ensure the appropriate and timely escalation of certain product
quality and pharmaceutical quality system issues.
2.6. Management review
a) Senior management should be responsible for pharmaceutical quality system governance through
management review to ensure its continuing suitability and effectiveness.
b) Management should assess the conclusions of periodic reviews of process performance and product
quality and of the pharmaceutical quality system, as described in Sections 3 and 4.
2.7. Management of outsourced activities and purchased materials
The pharmaceutical quality system, including the management responsibilities described in this
section, extends to the control and review of any outsourced activities and quality of purchased
materials. The pharmaceutical company is ultimately responsible to ensure processes are in place to
assure the control of outsourced activities and quality of purchased materials. These processes should
incorporate quality risk management and include:
a) Assessing prior to outsourcing operations or selecting material suppliers, the suitability and
competence of the other party to carry out the activity or provide the material using a defined
supply chain (e.g., audits, material evaluations, qualification);
b) Defining the responsibilities and communication processes for quality-related activities of the
involved parties. For outsourced activities, this should be included in a written agreement between
the contract giver and contract acceptor;
c) Monitoring and review of the performance of the contract acceptor or the quality of the material
from the provider, and the identification and implementation of any needed improvements;
d) Monitoring incoming ingredients and materials to ensure they are from approved sources using the
agreed supply chain.
2.8. Management of change in product ownership
When product ownership changes, (e.g., through acquisitions) management should consider the
complexity of this and ensure:
a) The ongoing responsibilities are defined for each company involved;
b) The necessary information is transferred.
11. IC H guideline Q10 on pharmaceutical quality system
EM A/CHMP/ICH/214732/2007 P age 10/20
3. Continual improvement of process performance and
product quality
This section describes the lifecycle stage goals and the four specific pharmaceutical quality system
elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in Section
1.5. It does not restate all regional GMP requirements.
3.1. Lifecycle stage goals
The goals of each product lifecycle stage are described below.
3.1.1. Pharmaceutical development
The goal of pharmaceutical development activities is to design a product and its manufacturing process
to consistently deliver the intended performance and meet the needs of patients and healthcare
professionals, and regulatory authorities and internal customers’ requirements. Approaches to
pharmaceutical development are described in ICH Q8. The results of exploratory and clinical
development studies, while outside the scope of this guidance, are inputs to pharmaceutical
development.
3.1.2. Technology transfer
The goal of technology transfer activities is to transfer product and process knowledge between
development and manufacturing, and within or between manufacturing sites to achieve product
realisation. This knowledge forms the basis for the manufacturing process, control strategy, process
validation approach and ongoing continual improvement.
3.1.3. Commercial manufacturing
The goals of manufacturing activities include achieving product realisation, establishing and
maintaining a state of control and facilitating continual improvement. The pharmaceutical quality
system should assure that the desired product quality is routinely met, suitable process performance is
achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated,
and the body of knowledge is continually expanded.
3.1.4. Product discontinuation
The goal of product discontinuation activities is to manage the terminal stage of the product lifecycle
effectively. For product discontinuation, a pre-defined approach should be used to manage activities
such as retention of documentation and samples and continued product assessment (e.g., complaint
handling and stability) and reporting in accordance with regulatory requirements.
3.2. Pharmaceutical quality system elements
The elements described below might be, required in part under regional GMP regulations. However, the
Q10 model’s intent is to enhance these elements in order to promote the lifecycle approach to product
quality. These four elements are:
Process performance and product quality monitoring system;
Corrective action and preventive action (CAPA) system;
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Change management system;
Management review of process performance and product quality.
These elements should be applied in a manner that is appropriate and proportionate to each of the
product lifecycle stages, recognising the differences among, and the different goals of, each stage.
Throughout the product lifecycle, companies are encouraged to evaluate opportunities for innovative
approaches to improve product quality.
Each element is followed by a table of example applications of the element to the stages of the
pharmaceutical lifecycle.
3.2.1. Process performance and product quality monitoring system
Pharmaceutical companies should plan and execute a system for the monitoring of process
performance and product quality to ensure a state of control is maintained. An effective monitoring
system provides assurance of the continued capability of processes and controls to produce a product
of desired quality and to identify areas for continual improvement. The process performance and
product quality monitoring system should:
a) Use quality risk management to establish the control strategy. This can include parameters and
attributes related to drug substance and drug product materials and components, facility and
equipment operating conditions, in-process controls, finished product specifications, and the
associated methods and frequency of monitoring and control. The control strategy should facilitate
timely feedback / feedforward and appropriate corrective action and preventive action;
b) Provide the tools for measurement and analysis of parameters and attributes identified in the
control strategy (e.g., data management and statistical tools);
c) Analyse parameters and attributes identified in the control strategy to verify continued operation
within a state of control;
d) Identify sources of variation affecting process performance and product quality for potential
continual improvement activities to reduce or control variation;
e) Include feedback on product quality from both internal and external sources, e.g., complaints,
product rejections, non-conformances, recalls, deviations, audits and regulatory inspections and
findings;
f) Provide knowledge to enhance process understanding, enrich the design space (where
established), and enable innovative approaches to process validation.
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Table 1. Application of process performance and product quality monitoring system throughout the
product lifecycle
Pharmaceutical
Development
Technology Transfer Commercial
Manufacturing
Product Discontinuation
Process and product
knowledge generated
and process and
product monitoring
conducted throughout
development can be
used to establish a
control strategy for
manufacturing.
Monitoring during
scale-up activities can
provide a preliminary
indication of process
performance and the
successful integration
into manufacturing.
Knowledge obtained
during transfer and
scale up activities can
be useful in further
developing the control
strategy.
A well-defined system
for process
performance and
product quality
monitoring should be
applied to assure
performance within a
state of control and to
identify improvement
areas.
Once manufacturing
ceases, monitoring
such as stability testing
should continue to
completion of the
studies. Appropriate
action on marketed
product should continue
to be executed
according to regional
regulations.
3.2.2. Corrective action and preventive action (CAPA) system
The pharmaceutical company should have a system for implementing corrective actions and preventive
actions resulting from the investigation of complaints, product rejections, non-conformances, recalls,
deviations, audits, regulatory inspections and findings, and trends from process performance and
product quality monitoring. A structured approach to the investigation process should be used with the
objective of determining the root cause. The level of effort, formality, and documentation of the
investigation should be commensurate with the level of risk, in line with ICH Q9. CAPA methodology
should result in product and process improvements and enhanced product and process understanding.
Table 2. Application of corrective action and preventive action system throughout the product lifecycle
Pharmaceutical
Development
Technology Transfer Commercial
Manufacturing
Product
Discontinuation
Product or process
variability is explored.
CAPA methodology is
useful where corrective
actions and preventive
actions are
incorporated into the
iterative design and
development process.
CAPA can be used as
an effective system for
feedback, feedforward
and continual
improvement.
CAPA should be used
and the effectiveness
of the actions should
be evaluated.
CAPA should continue
after the product is
discontinued. The
impact on product
remaining on the
market should be
considered as well as
other products which
might be impacted.
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3.2.3. Change management system
Innovation, continual improvement, the outputs of process performance and product quality
monitoring and CAPA drive change. In order to evaluate, approve and implement these changes
properly, a company should have an effective change management system. There is generally a
difference in formality of change management processes prior to the initial regulatory submission and
after submission, where changes to the regulatory filing might be required under regional
requirements.
The change management system ensures continual improvement is undertaken in a timely and
effective manner. It should provide a high degree of assurance there are no unintended consequences
of the change.
The change management system should include the following, as appropriate for the stage of the
lifecycle:
a) Quality risk management should be utilised to evaluate proposed changes. The level of effort and
formality of the evaluation should be commensurate with the level of risk;
b) Proposed changes should be evaluated relative to the marketing authorisation, including design
space, where established, and/or current product and process understanding. There should be an
assessment to determine whether a change to the regulatory filing is required under regional
requirements. As stated in ICH Q8, working within the design space is not considered a change
(from a regulatory filing perspective). However, from a pharmaceutical quality system standpoint,
all changes should be evaluated by a company’s change management system;
c) Proposed changes should be evaluated by expert teams contributing the appropriate expertise and
knowledge from relevant areas (e.g., Pharmaceutical Development, Manufacturing, Quality,
Regulatory Affairs and Medical), to ensure the change is technically justified. Prospective
evaluation criteria for a proposed change should be set;
d) After implementation, an evaluation of the change should be undertaken to confirm the change
objectives were achieved and that there was no deleterious impact on product quality.
Table 3. Application of change management system throughout the product lifecycle
Pharmaceutical
Development
Technology Transfer Commercial
Manufacturing
Product
Discontinuation
Change is an inherent
part of the
development process
and should be
documented; the
formality of the change
management process
should be consistent
with the stage of
pharmaceutical
development.
The change
management system
should provide
management and
documentation of
adjustments made to
the process during
technology transfer
activities.
A formal change
management system
should be in place for
commercial
manufacturing.
Oversight by the
quality unit should
provide assurance of
appropriate science
and risk based
assessments.
Any changes after
product
discontinuation should
go through an
appropriate change
management system.
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3.2.4. Management review of process performance and product quality
Management review should provide assurance that process performance and product quality are
managed over the lifecycle. Depending on the size and complexity of the company, management
review can be a series of reviews at various levels of management and should include a timely and
effective communication and escalation process to raise appropriate quality issues to senior levels of
management for review.
1) The management review system should include:
a) The results of regulatory inspections and findings, audits and other assessments, and
commitments made to regulatory authorities;
b) Periodic quality reviews, that can include:
i) Measures of customer satisfaction such as product quality complaints and recalls;
ii) Conclusions of process performance and product quality monitoring;
iii) The effectiveness of process and product changes including those arising from corrective
action and preventive actions.
c) Any follow-up actions from previous management reviews.
2) The management review system should identify appropriate actions, such as:
a) Improvements to manufacturing processes and products;
b) Provision, training and/or realignment of resources;
c) Capture and dissemination of knowledge.
Table 4. Application of management review of process performance and product quality throughout
the product lifecycle
Pharmaceutical
Development
Technology Transfer Commercial
Manufacturing
Product
Discontinuation
Aspects of
management review
can be performed to
ensure adequacy of
the product and
process design.
Aspects of
management review
should be performed
to ensure the
developed product and
process can be
manufactured at
commercial scale.
Management review
should be a structured
system, as described
above, and should
support continual
improvement.
Management review
should include such
items as product
stability and product
quality complaints.
4. Continual improvement of the pharmaceutical quality
system
This section describes activities that should be conducted to manage and continually improve the
pharmaceutical quality system.
4.1. Management review of the pharmaceutical quality system
Management should have a formal process for reviewing the pharmaceutical quality system on a
periodic basis. The review should include:
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1) Measurement of achievement of pharmaceutical quality system objectives;
2) Assessment of performance indicators that can be used to monitor the effectiveness of processes
within the pharmaceutical quality system, such as:
a) Complaint, deviation, CAPA and change management processes;
b) Feedback on outsourced activities;
c) Self-assessment processes including risk assessments, trending, and audits;
d) External assessments such as regulatory inspections and findings and customer audits.
4.2. Monitoring of internal and external factors impacting the
pharmaceutical quality system
Factors monitored by management can include:
a) Emerging regulations, guidance and quality issues that can impact the Pharmaceutical Quality
System;
b) Innovations that might enhance the pharmaceutical quality system;
c) Changes in business environment and objectives;
d) Changes in product ownership.
4.3. Outcomes of management review and monitoring
The outcome of management review of the pharmaceutical quality system and monitoring of internal
and external factors can include:
e) Improvements to the pharmaceutical quality system and related processes;
f) Allocation or reallocation of resources and/or personnel training;
g) Revisions to quality policy and quality objectives;
h) Documentation and timely and effective communication of the results of the management review
and actions, including escalation of appropriate issues to senior management.
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5. Glossary
ICH and ISO definitions are used in ICH Q10 where they exist. For the purpose of ICH Q10, where the
words “requirement”, “requirements” or “necessary” appear in an ISO definition, they do not
necessarily reflect a regulatory requirement. The source of the definition is identified in parentheses
after the definition. Where no appropriate ICH or ISO definition was available, an ICH Q10 de finition
was developed.
Capability of a Process:
Ability of a process to realise a product that will fulfil the requirements of that product. The concept of
process capability can also be defined in statistical terms. (ISO 9000:2005)
Change Management:
A systematic approach to proposing, evaluating, approving, implementing and reviewing changes. (ICH
Q10)
Continual Improvement:
Recurring activity to increase the ability to fulfil requirements. (ISO 9000:2005)
Control Strategy:
A planned set of controls, derived from current product and process understanding, that assures
process performance and product quality. The controls can include parameters and attributes related
to drug substance and drug product materials and components, facility and equipment operating
conditions, in-process controls, finished product specifications, and the associated methods and
frequency of monitoring and control. (ICH Q10)
Corrective Action:
Action to eliminate the cause of a detected non-conformity or other undesirable situation. NOTE:
Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent
occurrence. (ISO 9000:2005)
Design Space:
The multidimensional combination and interaction of input variables (e.g., material attributes) and
process parameters that have been demonstrated to provide assurance of quality. (ICH Q8)
Enabler:
A tool or process which provides the means to achieve an objective. (ICH Q10)
Feedback / Feedforward:
Feedback: The modification or control of a process or system by its results or effects.
Feedforward: The modification or control of a process using its anticipated results or effects. (Oxford
Dictionary of English. Oxford University Press; 2003)
Feedback/ feedforward can be applied technically in process control strategies and conceptually in
quality management. (ICH Q10)
Innovation:
The introduction of new technologies or methodologies. (ICH Q10)
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Knowledge Management:
Systematic approach to acquiring, analysing, storing, and disseminating information related to
products, manufacturing processes and components. (ICH Q10)
Outsourced Activities:
Activities conducted by a contract acceptor under a written agreement with a contract giver. (ICH Q10)
Performance Indicators:
Measurable values used to quantify quality objectives to reflect the performance of an organisation,
process or system, also known as “performance metrics” in some regions. (ICH Q10)
Pharmaceutical Quality System (PQS):
Management system to direct and control a pharmaceutical company with regard to quality. (ICH Q10
based upon ISO 9000:2005)
Preventive Action:
Action to eliminate the cause of a potential non-conformity or other undesirable potential situation.
NOTE: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent
recurrence. (ISO 9000:2005)
Product Realisation:
Achievement of a product with the quality attributes appropriate to meet the needs of patients, health
care professionals, and regulatory authorities (including compliance with marketing authorisation) and
internal customers requirements. (ICH Q10)
Quality:
The degree to which a set of inherent properties of a product, system or process fulfils requirements.
(ICH Q9)
Quality Manual:
Document specifying the quality management system of an organisation. (ISO 9000:2005)
Quality Objectives:
A means to translate the quality policy and strategies into measurable activities. (ICH Q10)
Quality Planning:
Part of quality management focused on setting quality objectives and specifying necessary operational
processes and related resources to fulfil the quality objectives. (ISO 9000:2005)
Quality Policy:
Overall intentions and direction of an organisation related to quality as formally expressed by senior
management. (ISO 9000:2005)
Quality Risk Management:
A systematic process for the assessment, control, communication and review of risks to the quality of
the drug (medicinal) product across the product lifecycle. (ICH Q9)
Senior Management:
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Person(s) who direct and control a company or site at the highest levels with the authority and
responsibility to mobilise resources within the company or site. (ICH Q10 based in part on ISO
9000:2005)
State of Control:
A condition in which the set of controls consistently provides assurance of continued process
performance and product quality. (ICH Q10)
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Annex 1
Potential Opportunities to Enhance Science and Risk Based Regulatory Approaches *
*Note: This annex reflects potential opportunities to enhance regulatory approaches.
The actual regulatory process will be determined by region.
Scenario Potential Opportunity
1. Comply with GMPs Compliance – status quo
2. Demonstrate effective
pharmaceutical quality system, including
effective use of quality risk management
principles (e.g., ICH Q9 and ICH Q10).
Opportunity to:
increase use of risk based approaches for
regulatory inspections.
3. Demonstrate product and process
understanding, including effective use of
quality risk management principles (e.g.,
ICH Q8 and ICH Q9).
Opportunity to:
facilitate science based pharmaceutical
quality assessment;
enable innovative approaches to process
validation;
establish real-time release mechanisms.
4. Demonstrate effective
pharmaceutical quality system and product
and process understanding, including the
use of quality risk management principles
(e.g., ICH Q8, ICH Q9 and ICH Q10).
Opportunity to:
increase use of risk based approaches for
regulatory inspections;
facilitate science based pharmaceutical
quality assessment;
optimise science and risk based post-
approval change processes to maximise
benefits from innovation and continual
improvement;
enable innovative approaches to process
validation;
establish real-time release mechanisms.
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Annex 2
Diagram of the ICH Q10 pharmaceutical quality system model
This diagram illustrates the major features of the ICH Q10 Pharmaceutical Quality System (PQS)
model. The PQS covers the entire lifecycle of a product including pharmaceutical development,
technology transfer, commercial manufacturing, and product discontinuation as illustrated by the upper
portion of the diagram. The PQS augments regional GMPs as illustrated in the diagram. The diagram
also illustrates that regional GMPs apply to the manufacture of investigational products.
The next horizontal bar illustrates the importance of management responsibilities explained in Section
2 to all stages of the product lifecycle. The following horizontal bar lists the PQS elements which serve
as the major pillars under the PQS model. These elements should be applied appropriately and
proportionally to each lifecycle stage recognising opportunities to identify areas for continual
improvement.
The bottom set of horizontal bars illustrates the enablers: knowledge management and quality risk
management, which are applicable throughout the lifecycle stages. These enablers support the PQS
goals of achieving product realisation, establishing and maintaining a state of control, and facilitating
continual improvement.