gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
This document outlines the requirements for factory premises manufacturing medical devices according to Schedule M-III of the Drugs and Cosmetics Rules 1945 in India. It discusses location, building, water supply, waste disposal, worker hygiene and medical facilities requirements. It also provides recommendations for equipment and space needed for manufacturing common medical devices like perfusion sets, syringes and needles. Manufacturers must follow good manufacturing practices and maintain processing and quality control records. Medical devices are classified based on risk into four classes from low to high risk.
This document outlines good manufacturing practices (GMP) for Ayurvedic, Siddha, and Unani medicines. It discusses infrastructure requirements for manufacturing facilities, including adequate space for receiving raw materials, manufacturing, quality control, finished goods storage, and offices. It also covers requirements for buildings, water supply, waste disposal, cleaning of containers, storage, and machinery/equipment. Worker health, clothing, sanitation, and medical services are also addressed. The objective is to ensure raw materials are authentic and contamination-free, manufacturing follows the proper process, quality control measures are in place, and the finished drug is of acceptable quality.
Schedule M is good manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products.
Schedule M is a part of drugs and cosmetics act, 1940.
Schedule M- І:Requirements of factory premises for manufacture of homoeopathic preparations.
Schedule M- ІІ: :Requirements of factory premises for manufacture of cosmetics.
Schedule M- ІІІ: :Requirements of factory premises for manufacture of medical devices.
Concept of rasashala w.s.r to gmp guidelinesDr Ganesh Naik
The document discusses Good Manufacturing Practices (GMP) for herbo-mineral Ayurvedic drugs. It defines GMP and current GMP (cGMP), and explains their importance in meeting worldwide demand while ensuring drug quality and safety. It outlines the key requirements for facilities, equipment, personnel, processes, quality control, packaging, and hygiene. Implementing GMP for herbo-mineral drugs per Indian law is challenging but necessary to protect consumers and access international markets.
Schedule-T describes the good manufacturing practices for ayurvedic, siddha, and unani medicines. It aims to ensure raw materials are authentic and free from contamination in order to maintain product standards. Schedule-T has seven components that cover infrastructural requirements, working space, storage areas, machinery and equipment, standard operating procedures, health and hygiene, and documentation and records. These components establish guidelines for facilities, sanitation, personnel hygiene, production processes, quality control, and record keeping.
The document outlines good manufacturing practices (GMP) that must be followed to produce safe products. It discusses personnel hygiene practices, facility requirements, storage practices, process equipment guidelines, cleaning and sanitation procedures, pest control measures, and documentation standards that are necessary to ensure product quality and safety.
This slides contain description about SCHEDULE T good manufacturing process of Indian system of medicine contains about the process of GMP in indian system of medicine...
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
This document outlines the requirements for factory premises manufacturing medical devices according to Schedule M-III of the Drugs and Cosmetics Rules 1945 in India. It discusses location, building, water supply, waste disposal, worker hygiene and medical facilities requirements. It also provides recommendations for equipment and space needed for manufacturing common medical devices like perfusion sets, syringes and needles. Manufacturers must follow good manufacturing practices and maintain processing and quality control records. Medical devices are classified based on risk into four classes from low to high risk.
This document outlines good manufacturing practices (GMP) for Ayurvedic, Siddha, and Unani medicines. It discusses infrastructure requirements for manufacturing facilities, including adequate space for receiving raw materials, manufacturing, quality control, finished goods storage, and offices. It also covers requirements for buildings, water supply, waste disposal, cleaning of containers, storage, and machinery/equipment. Worker health, clothing, sanitation, and medical services are also addressed. The objective is to ensure raw materials are authentic and contamination-free, manufacturing follows the proper process, quality control measures are in place, and the finished drug is of acceptable quality.
Schedule M is good manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products.
Schedule M is a part of drugs and cosmetics act, 1940.
Schedule M- І:Requirements of factory premises for manufacture of homoeopathic preparations.
Schedule M- ІІ: :Requirements of factory premises for manufacture of cosmetics.
Schedule M- ІІІ: :Requirements of factory premises for manufacture of medical devices.
Concept of rasashala w.s.r to gmp guidelinesDr Ganesh Naik
The document discusses Good Manufacturing Practices (GMP) for herbo-mineral Ayurvedic drugs. It defines GMP and current GMP (cGMP), and explains their importance in meeting worldwide demand while ensuring drug quality and safety. It outlines the key requirements for facilities, equipment, personnel, processes, quality control, packaging, and hygiene. Implementing GMP for herbo-mineral drugs per Indian law is challenging but necessary to protect consumers and access international markets.
Schedule-T describes the good manufacturing practices for ayurvedic, siddha, and unani medicines. It aims to ensure raw materials are authentic and free from contamination in order to maintain product standards. Schedule-T has seven components that cover infrastructural requirements, working space, storage areas, machinery and equipment, standard operating procedures, health and hygiene, and documentation and records. These components establish guidelines for facilities, sanitation, personnel hygiene, production processes, quality control, and record keeping.
The document outlines good manufacturing practices (GMP) that must be followed to produce safe products. It discusses personnel hygiene practices, facility requirements, storage practices, process equipment guidelines, cleaning and sanitation procedures, pest control measures, and documentation standards that are necessary to ensure product quality and safety.
This slides contain description about SCHEDULE T good manufacturing process of Indian system of medicine contains about the process of GMP in indian system of medicine...
This document provides an overview of Good Manufacturing Practices (GMP) and current GMP (cGMP). It discusses what GMP and cGMP are, the key aspects they cover, the ten principles of GMP, important GMP documents, and Schedule M which outlines GMP requirements for pharmaceutical manufacturing in India. Schedule M includes requirements for factory premises, production areas, warehousing, personnel, sanitation and other key aspects to help ensure quality standards during manufacturing.
This document provides information on the requirements for factory premises for manufacturing homeopathic preparations, cosmetics, and medical devices. It discusses the general requirements for location, buildings, water supply, waste disposal, and staff hygiene. It also outlines the specific plant and equipment needed for producing different types of homeopathic preparations like syrups and ointments, various cosmetic products like powders and creams, and medical devices like perfusion sets, syringes, and their component areas for molding, assembling, storage, washing, drying, sealing, sterilization, and testing.
This document outlines Good Manufacturing Practices (GMP) for the production of phytomedicines according to Ayurveda, Siddha, and Unani systems of medicine in India. It discusses requirements for facilities, equipment, personnel, documentation, raw materials storage, and quality control. The key points are:
- Facilities must be designed and maintained to allow hygienic production and prevent contamination. Equipment must be suitable for operations and cleaned regularly.
- Personnel involved in production and quality control must be qualified and receive training. Sanitary practices like health checks and protective clothing are required.
- Comprehensive documentation includes specifications, manufacturing processes, training records, and methods to investigate defective
The document discusses Good Manufacturing Practices (GMP) for herbal medicines in Indian systems of medicine. It outlines the key requirements for GMP compliance, including factory premises requirements, manufacturing processes, equipment, quality control, training, documentation, labeling and packing. The objectives of GMP are to ensure authentic and quality raw materials are used, manufacturing processes are standardized, and finished products meet predefined specifications to ensure consistent quality and minimize contamination and errors.
1. The document defines 33 terms related to good manufacturing practices for animal vaccines, including definitions for batch, calibration, contamination, documentation, final product, quality assurance, quality controls, raw materials, and standard operating procedure.
2. Key aspects of vaccine manufacturing covered include ensuring quality of starting materials and finished products through controls and monitoring at all stages of production. Proper facility design, equipment, personnel, and implementation of quality systems are required.
3. Batch records must document all circumstances pertaining to a batch's quality, and representative samples must be retained from each finished product batch.
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
This document provides an overview of Schedule M, which outlines Good Manufacturing Practices (GMP) regulations in India for pharmaceutical manufacturing. It discusses the requirements for facilities, equipment, documentation, quality control, personnel, packaging and labeling. The key points covered include specifications for premises and equipment location, water systems, waste disposal, storage areas, production facilities, sanitation procedures, raw material control, calibration of instruments, documentation of records, self-inspection practices, quality control testing, batch processing, packaging and labeling, validation, recalls and adverse event reporting. The goal of Schedule M is to ensure consistent production and quality control of pharmaceuticals manufactured in India.
This document provides guidance on ensuring sterility in the manufacture of sterile pharmaceutical products through aseptic processing. It discusses quality systems, personnel requirements, facility design, environmental monitoring, equipment qualification, sterilization processes, and other key aspects of aseptic manufacturing. The guidance is intended to advise sterile product manufacturers and regulators on assuring sterility in compliance with regulations.
The document outlines the Good Manufacturing Practices (GMP) as per Schedule M of the Drugs and Cosmetic Act of 1940 in India. It details the requirements for facilities, equipment, production, quality control, documentation, personnel and other aspects of pharmaceutical manufacturing. The key points covered include requirements for premises location, building design to prevent contamination, waste disposal procedures, manufacturing controls, quality control testing, documentation and record keeping, personnel qualifications, and compliance with other applicable regulations.
In this video Quality assurance parameters has been discussed for herbal medicines in herbal drug industry. The Current Good Manufacturing of Herbal Products also covered. What kinds of area is suitable for herbal plant, water supply, Exhaust facility, storage requirements etc explained.
Video link :
https://youtu.be/9T82HALfpy8
Portion Disscussed :
1. Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines
2. Quality assurance in the manufacture of herbal medicines
3. Good manufacturing practice for herbal medicines
4. Sanitation and hygiene in herbal Drug Industry
5. Qualification and validation in herbal Drug Industry
6. Complaints in herbal Drug Industry
7. Product recalls in herbal Drug Industry
8. Contract production and analysis in herbal Drug Industry
9. Self-inspection in herbal Drug Industry
10. Personnel in herbal Drug Industry
11. Training in herbal Drug Industry
12. Personal hygiene in herbal Drug Industry
13. Premises for herbal Drug Industry
14. Storage areas in herbal Drug Industry
15. Production areas in herbal Drug Industry
16. Equipment in herbal Drug Industry
17. Materials in herbal Drug Industry
18. Reference samples and standards in herbal Drug Industry
19. Packaging materials and labeling in herbal Drug Industry
The document outlines Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani drugs. It discusses requirements for factory premises, general building requirements, water supply, waste disposal, raw material and finished goods storage, and quality control facilities. Key points include:
1) Factory areas must be adequately sized and separated for raw material receipt and storage, manufacturing, quality control, and finished goods storage.
2) Buildings must allow hygienic production and be free of pests. Interior surfaces must be cleanable.
3) Raw materials must be stored by type in labeled containers indicating source, batch, and receipt date.
4) Finished goods are
This document outlines the Good Manufacturing Practice (GMP) regulations in India as specified in Schedule M. It discusses 16 sections covering various aspects of GMP compliance, including premises and equipment requirements, production procedures, sanitation, quality control testing, documentation, and self-inspection. The goal of GMP regulations is to ensure pharmaceutical products are consistently manufactured and controlled according to quality standards appropriate for their intended use.
This presentation describes Schedule M of Drugs & Cosmetic Act. It consists of Good Manufacturing Practices (GMP) for the manufacturing of drugs. Detailed guidelines about factory premises, machinery, process, quality control, etc. have been given.
This document summarizes the regulations for Ayurvedic, Siddha, and Unani drug manufacturing under Schedule T of the Drugs and Cosmetics Act. It outlines good manufacturing practices including requirements for facilities, equipment, production processes, quality control, record keeping, and specific machinery for different drug categories. Manufacturing premises must meet standards for space, ventilation, sanitation, and separation of activities. Detailed procedures are provided for batch manufacturing, distribution, complaints, and staff hygiene and health.
The document discusses the Good Manufacturing Practices (GMP) guidelines for Ayurvedic, Siddha, and Unani medicines as specified in Schedule T of the Drugs and Cosmetics Rules. It covers various components of GMP including factory premises requirements, machinery and equipment, production areas, raw material and finished goods storage, worker hygiene, and documentation. The objective of GMP is to ensure quality control throughout the manufacturing process to produce medicines of acceptable standards.
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
This document provides guidance for interpreting Good Manufacturing Practice (GMP) standards for pharmaceutical production as outlined in European Union directives. It discusses principles of production including competent personnel, written procedures, material checks, quarantining, storage conditions, cross-contamination prevention, and more. Revisions were made to sections regarding cross-contamination prevention and supplier qualification. The deadline for implementation is March 1, 2015, with some toxicological evaluation deadlines extending into 2015-2016.
Good Manufacturing Practices (GMP) regulations were introduced in 1988 and amended in 2001 to ensure pharmaceutical products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from starting materials to training and hygiene of staff. Detailed written procedures and documented proof of following correct procedures are required at each step of manufacturing. The goal is to minimize risks that cannot be detected by final testing and ensure consumers receive products of the specified quality.
This document provides an overview of Good Manufacturing Practices (GMP) and current GMP (cGMP). It discusses what GMP and cGMP are, the key aspects they cover, the ten principles of GMP, important GMP documents, and Schedule M which outlines GMP requirements for pharmaceutical manufacturing in India. Schedule M includes requirements for factory premises, production areas, warehousing, personnel, sanitation and other key aspects to help ensure quality standards during manufacturing.
This document provides information on the requirements for factory premises for manufacturing homeopathic preparations, cosmetics, and medical devices. It discusses the general requirements for location, buildings, water supply, waste disposal, and staff hygiene. It also outlines the specific plant and equipment needed for producing different types of homeopathic preparations like syrups and ointments, various cosmetic products like powders and creams, and medical devices like perfusion sets, syringes, and their component areas for molding, assembling, storage, washing, drying, sealing, sterilization, and testing.
This document outlines Good Manufacturing Practices (GMP) for the production of phytomedicines according to Ayurveda, Siddha, and Unani systems of medicine in India. It discusses requirements for facilities, equipment, personnel, documentation, raw materials storage, and quality control. The key points are:
- Facilities must be designed and maintained to allow hygienic production and prevent contamination. Equipment must be suitable for operations and cleaned regularly.
- Personnel involved in production and quality control must be qualified and receive training. Sanitary practices like health checks and protective clothing are required.
- Comprehensive documentation includes specifications, manufacturing processes, training records, and methods to investigate defective
The document discusses Good Manufacturing Practices (GMP) for herbal medicines in Indian systems of medicine. It outlines the key requirements for GMP compliance, including factory premises requirements, manufacturing processes, equipment, quality control, training, documentation, labeling and packing. The objectives of GMP are to ensure authentic and quality raw materials are used, manufacturing processes are standardized, and finished products meet predefined specifications to ensure consistent quality and minimize contamination and errors.
1. The document defines 33 terms related to good manufacturing practices for animal vaccines, including definitions for batch, calibration, contamination, documentation, final product, quality assurance, quality controls, raw materials, and standard operating procedure.
2. Key aspects of vaccine manufacturing covered include ensuring quality of starting materials and finished products through controls and monitoring at all stages of production. Proper facility design, equipment, personnel, and implementation of quality systems are required.
3. Batch records must document all circumstances pertaining to a batch's quality, and representative samples must be retained from each finished product batch.
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
This document provides an overview of Schedule M, which outlines Good Manufacturing Practices (GMP) regulations in India for pharmaceutical manufacturing. It discusses the requirements for facilities, equipment, documentation, quality control, personnel, packaging and labeling. The key points covered include specifications for premises and equipment location, water systems, waste disposal, storage areas, production facilities, sanitation procedures, raw material control, calibration of instruments, documentation of records, self-inspection practices, quality control testing, batch processing, packaging and labeling, validation, recalls and adverse event reporting. The goal of Schedule M is to ensure consistent production and quality control of pharmaceuticals manufactured in India.
This document provides guidance on ensuring sterility in the manufacture of sterile pharmaceutical products through aseptic processing. It discusses quality systems, personnel requirements, facility design, environmental monitoring, equipment qualification, sterilization processes, and other key aspects of aseptic manufacturing. The guidance is intended to advise sterile product manufacturers and regulators on assuring sterility in compliance with regulations.
The document outlines the Good Manufacturing Practices (GMP) as per Schedule M of the Drugs and Cosmetic Act of 1940 in India. It details the requirements for facilities, equipment, production, quality control, documentation, personnel and other aspects of pharmaceutical manufacturing. The key points covered include requirements for premises location, building design to prevent contamination, waste disposal procedures, manufacturing controls, quality control testing, documentation and record keeping, personnel qualifications, and compliance with other applicable regulations.
In this video Quality assurance parameters has been discussed for herbal medicines in herbal drug industry. The Current Good Manufacturing of Herbal Products also covered. What kinds of area is suitable for herbal plant, water supply, Exhaust facility, storage requirements etc explained.
Video link :
https://youtu.be/9T82HALfpy8
Portion Disscussed :
1. Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines
2. Quality assurance in the manufacture of herbal medicines
3. Good manufacturing practice for herbal medicines
4. Sanitation and hygiene in herbal Drug Industry
5. Qualification and validation in herbal Drug Industry
6. Complaints in herbal Drug Industry
7. Product recalls in herbal Drug Industry
8. Contract production and analysis in herbal Drug Industry
9. Self-inspection in herbal Drug Industry
10. Personnel in herbal Drug Industry
11. Training in herbal Drug Industry
12. Personal hygiene in herbal Drug Industry
13. Premises for herbal Drug Industry
14. Storage areas in herbal Drug Industry
15. Production areas in herbal Drug Industry
16. Equipment in herbal Drug Industry
17. Materials in herbal Drug Industry
18. Reference samples and standards in herbal Drug Industry
19. Packaging materials and labeling in herbal Drug Industry
The document outlines Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani drugs. It discusses requirements for factory premises, general building requirements, water supply, waste disposal, raw material and finished goods storage, and quality control facilities. Key points include:
1) Factory areas must be adequately sized and separated for raw material receipt and storage, manufacturing, quality control, and finished goods storage.
2) Buildings must allow hygienic production and be free of pests. Interior surfaces must be cleanable.
3) Raw materials must be stored by type in labeled containers indicating source, batch, and receipt date.
4) Finished goods are
This document outlines the Good Manufacturing Practice (GMP) regulations in India as specified in Schedule M. It discusses 16 sections covering various aspects of GMP compliance, including premises and equipment requirements, production procedures, sanitation, quality control testing, documentation, and self-inspection. The goal of GMP regulations is to ensure pharmaceutical products are consistently manufactured and controlled according to quality standards appropriate for their intended use.
This presentation describes Schedule M of Drugs & Cosmetic Act. It consists of Good Manufacturing Practices (GMP) for the manufacturing of drugs. Detailed guidelines about factory premises, machinery, process, quality control, etc. have been given.
This document summarizes the regulations for Ayurvedic, Siddha, and Unani drug manufacturing under Schedule T of the Drugs and Cosmetics Act. It outlines good manufacturing practices including requirements for facilities, equipment, production processes, quality control, record keeping, and specific machinery for different drug categories. Manufacturing premises must meet standards for space, ventilation, sanitation, and separation of activities. Detailed procedures are provided for batch manufacturing, distribution, complaints, and staff hygiene and health.
The document discusses the Good Manufacturing Practices (GMP) guidelines for Ayurvedic, Siddha, and Unani medicines as specified in Schedule T of the Drugs and Cosmetics Rules. It covers various components of GMP including factory premises requirements, machinery and equipment, production areas, raw material and finished goods storage, worker hygiene, and documentation. The objective of GMP is to ensure quality control throughout the manufacturing process to produce medicines of acceptable standards.
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
This document provides guidance for interpreting Good Manufacturing Practice (GMP) standards for pharmaceutical production as outlined in European Union directives. It discusses principles of production including competent personnel, written procedures, material checks, quarantining, storage conditions, cross-contamination prevention, and more. Revisions were made to sections regarding cross-contamination prevention and supplier qualification. The deadline for implementation is March 1, 2015, with some toxicological evaluation deadlines extending into 2015-2016.
Good Manufacturing Practices (GMP) regulations were introduced in 1988 and amended in 2001 to ensure pharmaceutical products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from starting materials to training and hygiene of staff. Detailed written procedures and documented proof of following correct procedures are required at each step of manufacturing. The goal is to minimize risks that cannot be detected by final testing and ensure consumers receive products of the specified quality.
Phụ lục 1 tiêu chuẩn GMP EU về sản xuất thuốc vô trùng trong đó có các tiêu chuẩn về:
1. Hệ thống chất lượng thuốc vô trùng.
2. Nhân sự trong nhà máy thuốc vô trùng.
3. Nhà xưởng, trang thiết bị nhà máy thuốc vô trùng.
4. Hệ thống phụ trợ nhà máy thuốc vô trùng.
5. Công nghệ sản xuất.
6. Hệ thống giám sát, quản lý môi trường sản xuất và quá trình vận hành.
7. Kiểm soát chất lượng thành phẩm đầu ra
Phụ lục 3 tiêu chuẩn GMP EU về sản xuất thuốc thú y miễn dịch bao gồm:
1. Hệ thống chất lượng.
2. Nhân sự trong nhà máy thuốc thú y miễn dịch.
3. Nhà xưởng, trang thiết bị nhà máy thuốc thú y miễn dịch.
4. Hệ thống phụ trợ nhà máy thuốc thú y miễn dịch.
5. Công nghệ sản xuất.
6. Hệ thống giám sát, quản lý môi trường sản xuất và quá trình vận hành.
7. Kiểm soát chất lượng thành phẩm đầu ra
The document provides guidance on the manufacture of immunological veterinary medicinal products. It discusses several key aspects:
1) Personnel working in these facilities require specific training and protective measures due to the risks posed by handling pathogenic biological agents.
2) Premises must be designed to control risks to both products and the environment, with different containment levels depending on the pathogenicity of the agents. Live agents should be handled in contained areas.
3) Production processes require adherence to validated procedures and in-process controls due to the complex nature and variability of biological processes used. Special consideration is given to starting materials, media, and seed lot/cell bank systems.
This document provides guidelines for good manufacturing practices for biological products. It outlines the scope, which includes growing microorganisms, extracting substances from tissues, recombinant DNA techniques, hybridoma techniques, and propagating microorganisms in embryos or animals. Biological products covered include allergens, antigens, vaccines, hormones, enzymes, blood and plasma derivatives, immune sera, immunoglobulins, products of fermentation, and diagnostic agents. The principles discuss adhering to good manufacturing practices and controlling biological products through biological techniques. Specific areas covered include personnel, premises and equipment, animal quarters and care, production, labeling, records, quality assurance and control.
This document provides an overview of requirements for Good Manufacturing Practices (GMP), Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), USFDA guidelines, and ISO 9000 standards. It discusses key elements of GMP/cGMP including facilities, equipment, documentation, quality control, and compliance. It also outlines 10 key principles of GLP relating to test facility organization, quality assurance, facilities, equipment, test systems, substances, standard operating procedures, performance, reporting and record keeping. The document is intended to present information on regulatory standards for pharmaceutical manufacturing and laboratory testing.
The document discusses Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It outlines requirements for facilities, equipment, personnel, documentation, production processes, quality control, and other operational aspects to minimize risks and ensure consistent production of quality products. GMP covers all aspects of production and testing to maintain standards, prevent contamination and errors, and comply with regulatory guidelines.
cGMP as per shedule M outlines the Good Manufacturing Practices that must be followed for pharmaceutical manufacturing according to the Drugs and Cosmetics Act of India. It covers requirements for facilities, equipment, personnel, sanitation, documentation, quality control, packaging and labeling. All aspects of production from raw materials to finished products must meet GMP standards to ensure consistency and quality of manufactured drugs. Detailed written procedures and records are required for all manufacturing processes.
This document provides an overview of Good Manufacturing Practices (GMP) in the pharmaceutical industry. It defines GMP and discusses why GMP is important to ensure consistent quality products and protect consumer safety. The document outlines the key principles of GMP, including facilities and equipment design, validation, documentation, quality control systems, and self-inspection. It also reviews specific GMP requirements for premises, equipment, raw materials, production, sanitation, quality audits, and more. Adhering to GMP regulations helps pharmaceutical manufacturers minimize risks and ensure their products are safe, pure, and effective.
The document outlines WHO guidelines for good manufacturing practices (GMP) in the pharmaceutical industry. It discusses how GMP ensures quality control throughout the production process, from procurement of materials to finished products. Key aspects covered include facilities and equipment qualification, sanitary conditions, documentation practices, personnel training, and quality control testing. Adhering to GMP is important for minimizing risks and ensuring patient safety.
Design and Construction of plant as per the GMP Guidelines.pdfMohiniTawade
GMP is that part of Quality assurance which ensures that the products are consistently
manufactured and controlled to the Quality standards appropriate to their intended use
To compare GMP requirement of India, US and Europe for tablets.Aakashdeep Raval
The document discusses Good Manufacturing Practice (GMP) requirements for tablet manufacturing in India, the US, and Europe. It provides an in-depth overview of key GMP requirements for tablet production in India, covering general facility requirements, warehousing, production areas, ancillary areas, quality control, personnel, manufacturing operations, equipment, documentation, quality assurance, and validation. The guidelines outline aspects of production and testing that impact quality, including clearly defined and controlled manufacturing processes, change control, training, facilities, equipment, and documentation.
1. The document discusses key concepts in pharmaceutical quality including GMP, QA, QC, validation, and contamination control. It provides definitions and explanations of these terms.
2. GMP regulations require manufacturers to ensure product quality and safety. The document outlines 17 key parameters that pharmaceutical companies must follow under GMP.
3. Contamination can occur through particulates, chemicals, or microbes. The document describes major sources of each type of contamination and how they can be controlled.
This document defines key terms related to Good Manufacturing Practice (GMP) for pharmaceuticals. It discusses GMP requirements for facilities, equipment, documentation, materials, processes, quality control, quality assurance, personnel, sanitation, complaints, and recalls. Key points include that GMP aims to consistently produce quality medicines through validated processes and facilities, qualified staff, appropriate materials and equipment, and defined procedures. Quality assurance covers all activities influencing quality, while quality control tests and releases products. Personnel must be properly trained and hygienic practices followed.
GMP is a set of principles and procedures that ensure products are consistently manufactured and controlled according to quality standards for their intended use. Key aspects of GMP include requirements for facilities, equipment, personnel, documentation, raw materials, production, packaging and labeling, quality control, self-inspection and product recalls. GMP regulations in India were introduced in 1988 and amended in 2001, embracing rules under the Drugs and Cosmetics Rules 1945. Facilities must be designed and maintained to allow production under hygienic conditions in order to prevent contamination and cross-contamination.
Objectives and policies of cGMP & Inventory management and controlArul Packiadhas
This document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management and control. It outlines the importance of CGMP in assuring quality standards and preventing issues. CGMP regulations provide systems to properly design, monitor, and control manufacturing processes. The document also describes objectives of inventory control such as minimizing costs and ensuring adequate stock levels. It provides details on inventory management policies, documentation requirements, and quality control standards under CGMP.
1. The document discusses Good Manufacturing Practices (GMP) regulations for Schedule M drugs and cosmetics in India.
2. It covers GMP requirements for premises, equipment, sanitation, personnel, production, quality control, documentation and other areas to ensure consistent high quality of pharmaceutical products.
3. Key aspects include requirements for manufacturing facilities, warehouses, equipment calibration, personnel training, hygiene, production supervision, validation of cleaning procedures, and maintenance of records to allow traceability of all manufacturing steps.
STERILE AND BULK MANUFACTURING. final.pptxPartha70
This document discusses sterile and bulk manufacturing in hospitals. It covers several key points:
1) Hospitals are increasingly manufacturing some medical items internally rather than purchasing everything externally. This includes sterile products as well as non-sterile items.
2) When manufacturing internally, hospitals must consider factors like production capacity, staffing needs, quality control testing, and operating costs.
3) For sterile manufacturing specifically, selection of components, facilities, packaging and quality control processes are important to prevent contamination and ensure sterility. Proper filtration and sterilization of air, containers, and other materials is required.
Infection Control Guidelines for Pharmacy [compatibility mode]drnahla
This document provides guidelines for pharmaceutical staff on proper procedures for preparing, storing, and monitoring sterile products in the pharmacy in order to prevent contamination, including following aseptic technique and using engineering controls like laminar airflow hoods when compounding intravenous medications, as well as procedures for quality control monitoring, storage and specific considerations for multidose vials. Adherence to these guidelines is important to avoid patient morbidity and mortality that can result from contaminated pharmaceuticals.
Similar to Tiêu chuẩn GMP EU chương 5. Tiêu chí Sản xuất (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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Tiêu chuẩn GMP EU chương 5. Tiêu chí Sản xuất
1. Ref. Ares(2015)283689 - 23/01/2015
EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Health systems and products
Medicinal products – quality, safety and efficacy
Brussels, 13 August 2014
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
EU Guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and Veterinary Use
Part 1
Chapter 5: Production
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on
the Community code relating to medicinal products for human use and Article 51 of Directive
2001/82/EC on the Community code relating to veterinary medicinal products. This document
provides guidance for the interpretation of the principles and guidelines of good
manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC
for medicinal products for human use and Directive 91/412/EEC for veterinary use.
Status of the document: Revisiona.
Reasons for changes: Changes have been made to sections 17 to 21, including adding a new
section, to improve the guidance on prevention of cross-contamination and to refer to
toxicological assessment. Changes were also introduced in sections 27 to 30, including adding
a new section, on the qualification of suppliers in order to reflect the legal obligation of
manufacturing authorisation holders to ensure that active substances are produced in
accordance with GMP. The changes include supply chain traceability. Sections 35 and 36 are
inserted to clarify and harmonise expectations of manufacturers regarding the testing of
starting materials while section 71 introduces guidance on notification of restrictions in
supply.
Deadline for coming into operation: 1 March 2015. However, the toxicological evaluation
mentioned in section 20 has to be carried out:
2. 2
from 1 June 2015 onwards for any medicinal product newly introduced into shared
manufacturing facilities;
before 1 December 2015 for medicinal products already produced in a shared
manufacturing facility producing only medicinal products for human use or producing
both medicinal products for human use and veterinary medicinal products on 31 May
2015;
before 1 June 2016 for veterinary medicinal products already produced in a shared
manufacturing facility producing only veterinary medicinal products on 31 May 2015.
3. 3
Principle
Production operations must follow clearly defined procedures; they must comply with the
principles of Good Manufacturing Practice in order to obtain products of the requisite quality
and be in accordance with the relevant manufacturing and marketing authorisations.
General
5.1 Production should be performed and supervised by competent people.
5.2 All handling of materials and products, such as receipt and quarantine, sampling,
storage, labelling, dispensing, processing, packaging and distribution should be done in
accordance with written procedures or instructions and, where necessary, recorded.
5.3 All incoming materials should be checked to ensure that the consignment corresponds
to the order. Containers should be cleaned where necessary and labelled with the
prescribed data.
5.4 Damage to containers and any other problem which might adversely affect the quality
of a material should be investigated, recorded and reported to the Quality Control
Department.
5.5 Incoming materials and finished products should be physically or administratively
quarantined immediately after receipt or processing, until they have been released for
use or distribution.
5.6 Intermediate and bulk products purchased as such should be handled on receipt as
though they were starting materials.
5.7 All materials and products should be stored under the appropriate conditions established
by the manufacturer and in an orderly fashion to permit batch segregation and stock
rotation.
5.8 Checks on yields, and reconciliation of quantities, should be carried out as necessary to
ensure that there are no discrepancies outside acceptable limits.
5.9 Operations on different products should not be carried out simultaneously or
consecutively in the same room unless there is no risk of mix-up or cross-
contamination.
5.10 At every stage of processing, products and materials should be protected from microbial
and other contamination.
5.11 When working with dry materials and products, special precautions should be taken to
prevent the generation and dissemination of dust. This applies particularly to the
handling of highly active or sensitising materials.
5.12 At all times during processing, all materials, bulk containers, major items of equipment
and where appropriate rooms used should be labelled or otherwise identified with an
indication of the product or material being processed, its strength (where applicable)
and batch number. Where applicable, this indication should also mention the stage of
production.
4. 4
5.13 Labels applied to containers, equipment or premises should be clear, unambiguous and
in the company’s agreed format. It is often helpful in addition to the wording on the
labels to use colours to indicate status (for example, quarantined, accepted, rejected,
clean).
5.14 Checks should be carried out to ensure that pipelines and other pieces of equipment
used for the transportation of products from one area to another are connected in a
correct manner.
5.15 Any deviation from instructions or procedures should be avoided as far as possible. If a
deviation occurs, it should be approved in writing by a competent person, with the
involvement of the Quality Control department when appropriate.
5.16 Access to production premises should be restricted to authorised personnel.
Prevention of cross-contamination in production
5.17 Normally, the production of non-medicinal products should be avoided in areas and
with equipment destined for the production of medicinal products but, where justified,
could be allowed where the measures to prevent cross-contamination with medicinal
products described below and in Chapter 3 can be applied. The production and/or
storage of technical poisons, such as pesticides (except where these are used for
manufacture of medicinal products) and herbicides, should not be allowed in areas used
for the manufacture and / or storage of medicinal products.
5.18 Contamination of a starting material or of a product by another material or product
should be prevented. This risk of accidental cross-contamination resulting from the
uncontrolled release of dust, gases, vapours, aerosols, genetic material or organisms
from active substances, other starting materials, and products in process, from residues
on equipment, and from operators’ clothing should be assessed. The significance of this
risk varies with the nature of the contaminant and that of the product being
contaminated. Products in which cross-contamination is likely to be most significant
are those administered by injection and those given over a long time. However,
contamination of all products poses a risk to patient safety dependent on the nature and
extent of contamination.
5.19 Cross-contamination should be prevented by attention to design of the premises and
equipment as described in Chapter 3. This should be supported by attention to process
design and implementation of any relevant technical or organizational measures,
including effective and reproducible cleaning processes to control risk of cross-
contamination.
5.20A Quality Risk Management process, which includes a potency and toxicological
evaluation, should be used to assess and control the cross-contamination risks presented
by the products manufactured. Factors including; facility/equipment design and use,
personnel and material flow, microbiological controls, physico-chemical characteristics
of the active substance, process characteristics, cleaning processes and analytical
capabilities relative to the relevant limits established from the evaluation of the products
should also be taken into account. The outcome of the Quality Risk Management
process should be the basis for determining the necessity for and extent to which
premises and equipment should be dedicated to a particular product or product family.
This may include dedicating specific product contact parts or dedication of the entire
manufacturing facility. It may be acceptable to confine manufacturing activities to a
5. 5
segregated, self contained production area within a multiproduct facility, where
justified.
5.21 The outcome of the Quality Risk Management process should be the basis for
determining the extent of technical and organisational measures required to control risks
for cross-contamination. These could include, but are not limited to, the following:
Technical Measures
i. Dedicated manufacturing facility (premises and equipment);
ii. Self-contained production areas having separate processing equipment and
separate heating, ventilation and air-conditioning (HVAC) systems. It may also be
desirable to isolate certain utilities from those used in other areas;
iii. Design of manufacturing process, premises and equipment to minimize
opportunities for cross-contamination during processing, maintenance and
cleaning;
iv. Use of “closed systems” for processing and material/product transfer between
equipment;
v. Use of physical barrier systems, including isolators, as containment measures;
vi. Controlled removal of dust close to source of the contaminant e.g. through
localised extraction;
vii. Dedication of equipment, dedication of product contact parts or dedication of
selected parts which are harder to clean (e.g. filters), dedication of maintenance
tools;
viii. Use of single use disposable technologies;
ix. Use of equipment designed for ease of cleaning;
x. Appropriate use of air-locks and pressure cascade to confine potential airborne
contaminant within a specified area;
xi. Minimising the risk of contamination caused by recirculation or re-entry of
untreated or insufficiently treated air;
xii. Use of automatic clean in place systems of validated effectiveness;
xiii. For common general wash areas, separation of equipment washing, drying and
storage areas.
Organisational Measures
i. Dedicating the whole manufacturing facility or a self contained production area on
a campaign basis (dedicated by separation in time) followed by a cleaning process
of validated effectiveness;
ii. Keeping specific protective clothing inside areas where products with high risk of
cross-contamination are processed;
iii. Cleaning verification after each product campaign should be considered as a
detectability tool to support effectiveness of the Quality Risk Management
approach for products deemed to present higher risk;
6. 6
iv. Depending on the contamination risk, verification of cleaning of non product
contact surfaces and monitoring of air within the manufacturing area and/or
adjoining areas in order to demonstrate effectiveness of control measures against
airborne contamination or contamination by mechanical transfer;
v. Specific measures for waste handling, contaminated rinsing water and soiled
gowning;
vi. Recording of spills, accidental events or deviations from procedures;
vii. Design of cleaning processes for premises and equipment such that the cleaning
processes in themselves do not present a cross-contamination risk;
viii. Design of detailed records for cleaning processes to assure completion of cleaning
in accordance with approved procedures and use of cleaning status labels on
equipment and manufacturing areas;
ix. Use of common general wash areas on a campaign basis;
x. Supervision of working behaviour to ensure training effectiveness and compliance
with the relevant procedural controls.
5.22 Measures to prevent cross-contamination and their effectiveness should be reviewed
periodically according to set procedures.
Validation
5.23 Validation studies should reinforce Good Manufacturing Practice and be conducted in
accordance with defined procedures. Results and conclusions should be recorded.
5.24 When any new manufacturing formula or method of preparation is adopted, steps should
be taken to demonstrate its suitability for routine processing. The defined process, using
the materials and equipment specified, should be shown to yield a product consistently
of the required quality.
5.25 Significant amendments to the manufacturing process, including any change in
equipment or materials, which may affect product quality and/or the reproducibility of
the process, should be validated.
5.26 Processes and procedures should undergo periodic critical re-validation to ensure that
they remain capable of achieving the intended results.
Starting materials
5.27 The selection, qualification, approval and maintenance of suppliers of starting materials,
together with their purchase and acceptance, should be documented as part of the
pharmaceutical quality system. The level of supervision should be proportionate to the
risks posed by the individual materials, taking account of their source, manufacturing
process, supply chain complexity and the final use to which the material is put in the
medicinal product. The supporting evidence for each supplier / material approval should
be maintained. Staff involved in these activities should have a current knowledge of the
suppliers, the supply chain and the associated risks involved. Where possible, starting
materials should be purchased directly from the manufacturer of the starting material.
7. 7
5.28 The quality requirements established by the manufacturer for the starting materials
should be discussed and agreed with the suppliers. Appropriate aspects of the
production, testing and control, including handling, labelling, packaging and
distribution requirements, complaints, recalls and rejection procedures should be
documented in a formal quality agreement or specification.
5.29 For the approval and maintenance of suppliers of active substances and excipients, the
following is required:
Active substances1
Supply chain traceability should be established and the associated risks, from active
substance starting materials to the finished medicinal product, should be formally
assessed and periodically verified. Appropriate measures should be put in place to
reduce risks to the quality of the active substance.
The supply chain and traceability records for each active substance (including active
substance starting materials) should be available and be retained by the EEA based
manufacturer or importer of the medicinal product.
Audits should be carried out at the manufacturers and distributors of active substances
to confirm that they comply with the relevant good manufacturing practice and good
distribution practice requirements. The holder of the manufacturing authorisation shall
verify such compliance either by himself or through an entity acting on his behalf under
a contract. For veterinary medicinal products, audits should be conducted based on risk.
Audits should be of an appropriate duration and scope to ensure that a full and clear
assessment of GMP is made; consideration should be given to potential cross-
contamination from other materials on site. The report should fully reflect what was
done and seen on the audit with any deficiencies clearly identified. Any required
corrective and preventive actions should be implemented.
Further audits should be undertaken at intervals defined by the quality risk management
process to ensure the maintenance of standards and continued use of the approved
supply chain.
Excipients
Excipients and excipient suppliers should be controlled appropriately based on the
results of a formalised quality risk assessment in accordance with the European
Commission ‘Guidelines on the formalised risk assessment for ascertaining the
appropriate Good Manufacturing Practice for excipients of medicinal products for
human use’.
5.30 For each delivery of starting material the containers should be checked for integrity of
package, including tamper evident seal where relevant, and for correspondence between
the delivery note, the purchase order, the supplier’s labels and approved manufacturer
and supplier information maintained by the medicinal product manufacturer. The
receiving checks on each delivery should be documented.
8. 8
5.31 If one material delivery is made up of different batches, each batch must be considered
as separate for sampling, testing and release.
5.32 Starting materials in the storage area should be appropriately labelled (see section 13).
Labels should bear at least the following information:
i. The designated name of the product and the internal code reference where
applicable;
ii. A batch number given at receipt;
iii. Where appropriate, the status of the contents (e.g. in quarantine, on test, released,
rejected);
iv. Where appropriate, an expiry date or a date beyond which retesting is necessary.
When fully computerised storage systems are used, all the above information need not
necessarily be in a legible form on the label.
5.33 There should be appropriate procedures or measures to assure the identity of the
contents of each container of starting material. Bulk containers from which samples
have been drawn should be identified (see Chapter 6).
5.34 Only starting materials which have been released by the Quality Control department and
which are within their retest period should be used.
5.35 Manufacturers of finished products are responsible for any testing of starting materials2
as described in the marketing authorisation dossier. They can utilise partial or full test
results from the approved starting material manufacturer but must, as a minimum,
perform identification testing3 of each batch according to Annex 8.
5.36 The rationale for the outsourcing of this testing should be justified and documented and
the following requirements should be fulfilled:
i. Special attention should be paid to the distribution controls (transport,
wholesaling, storage and delivery) in order to maintain the quality characteristics
of the starting materials and to ensure that test results remain applicable to the
delivered material;
ii. The medicinal product manufacturer should perform audits, either itself or via
third parties, at appropriate intervals based on risk at the site(s) carrying out the
testing (including sampling) of the starting materials in order to assure compliance
with Good Manufacturing Practice and with the specifications and testing methods
described in the marketing authorisation dossier;
iii. The certificate of analysis provided by the starting material manufacturer/supplier
should be signed by a designated person with appropriate qualifications and
experience. The signature assures that each batch has been checked for compliance
with the agreed product specification unless this assurance is provided separately;
iv. The medicinal product manufacturer should have appropriate experience in dealing
with the starting material manufacturer (including experience via a supplier)
2 A similar approach should apply to packaging materials as stated in section 5.45.
3 Identity testing of starting materials should be performed according to the methods and the specifications of the
relevant marketing authorisation dossier.
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including assessment of batches previously received and the history of compliance
before reducing in-house testing. Any significant change in the manufacturing or
testing processes should be considered;
v. The medicinal product manufacturer should also perform (or via a separately
approved contract laboratory) a full analysis at appropriate intervals based on risk
and compare the results with the material manufacturer or supplier’s certificate of
analysis in order to check the reliability of the latter. Should this testing identify
any discrepancy then an investigation should be performed and appropriate
measures taken. The acceptance of certificates of analysis from the material
manufacturer or supplier should be discontinued until these measures are
completed.
5.37 Starting materials should only be dispensed by designated persons, following a written
procedure, to ensure that the correct materials are accurately weighed or measured into
clean and properly labelled containers.
5.38 Each dispensed material and its weight or volume should be independently checked and
the check recorded.
5.39 Materials dispensed for each batch should be kept together and conspicuously labelled
as such.
Processing operations: intermediate and bulk products
5.40 Before any processing operation is started, steps should be taken to ensure that the work
area and equipment are clean and free from any starting materials, products, product
residues or documents not required for the current operation.
5.41 Intermediate and bulk products should be kept under appropriate conditions.
5.42 Critical processes should be validated (see "Validation" in this Chapter).
5.43 Any necessary in-process controls and environmental controls should be carried out and
recorded.
5.44 Any significant deviation from the expected yield should be recorded and investigated.
Packaging materials
5.45 The selection, qualification, approval and maintenance of suppliers of primary and
printed packaging materials shall be accorded attention similar to that given to starting
materials.
5.46 Particular attention should be paid to printed materials. They should be stored in
adequately secure conditions such as to exclude unauthorised access. Cut labels and
other loose printed materials should be stored and transported in separate closed
containers so as to avoid mix-ups. Packaging materials should be issued for use only by
authorised personnel following an approved and documented procedure.
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5.47 Each delivery or batch of printed or primary packaging material should be given a
specific reference number or identification mark.
5.48 Outdated or obsolete primary packaging material or printed packaging material should
be destroyed and this disposal recorded.
Packaging operations
5.49 When setting up a programme for the packaging operations, particular attention should
be given to minimising the risk of cross-contamination, mix-ups or substitutions.
Different products should not be packaged in close proximity unless there is physical
segregation.
5.50 Before packaging operations are begun, steps should be taken to ensure that the work
area, packaging lines, printing machines and other equipment are clean and free from
any products, materials or documents previously used, if these are not required for the
current operation. The line-clearance should be performed according to an appropriate
check-list.
5.51 The name and batch number of the product being handled should be displayed at each
packaging station or line.
5.52 All products and packaging materials to be used should be checked on delivery to the
packaging department for quantity, identity and conformity with the Packaging
Instructions.
5.53 Containers for filling should be clean before filling. Attention should be given to avoid
and remove any contaminants such as glass fragments and metal particles.
5.54 Normally, filling and sealing should be followed as quickly as possible by labelling. If it
is not the case, appropriate procedures should be applied to ensure that no mix-ups or
mislabelling can occur.
5.55 The correct performance of any printing operation (for example code numbers, expiry
dates) to be done separately or in the course of the packaging should be checked and
recorded. Attention should be paid to printing by hand which should be re-checked at
regular intervals.
5.56 Special care should be taken when using cut-labels and when over-printing is carried
out off-line. Roll-feed labels are normally preferable to cut-labels, in helping to avoid
mix-ups.
5.57 Checks should be made to ensure that any electronic code readers, label counters or
similar devices are operating correctly.
5.58 Printed and embossed information on packaging materials should be distinct and
resistant to fading or erasing.
5.59 On-line control of the product during packaging should include at least checking the
following:
i. General appearance of the packages;
ii. Whether the packages are complete;
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iii. Whether the correct products and packaging materials are used;
iv. Whether any over-printing is correct;
v. Correct functioning of line monitors.
Samples taken away from the packaging line should not be returned.
5.60 Products which have been involved in an unusual event should only be reintroduced
into the process after special inspection, investigation and approval by authorised
personnel. Detailed record should be kept of this operation.
5.61 Any significant or unusual discrepancy observed during reconciliation of the amount of
bulk product and printed packaging materials and the number of units produced should
be investigated and satisfactorily accounted for before release.
5.62 Upon completion of a packaging operation, any unused batch-coded packaging
materials should be destroyed and the destruction recorded. A documented procedure
should be followed if un-coded printed materials are returned to stock.
Finished products
5.63 Finished products should be held in quarantine until their final release under conditions
established by the manufacturer.
5.64 The evaluation of finished products and documentation which is necessary before
release of product for sale is described in Chapter 6 (Quality Control).
5.65 After release, finished products should be stored as usable stock under conditions
established by the manufacturer.
Rejected, recovered and returned materials
5.66 Rejected materials and products should be clearly marked as such and stored separately
in restricted areas. They should either be returned to the suppliers or, where appropriate,
reprocessed or destroyed. Whatever action is taken should be approved and recorded by
authorised personnel.
5.67 The reprocessing of rejected products should be exceptional. It is only permitted if the
quality of the final product is not affected, if the specifications are met and if it is done
in accordance with a defined and authorised procedure after evaluation of the risks
involved. Record should be kept of the reprocessing.
5.68 The recovery of all or part of earlier batches which conform to the required quality by
incorporation into a batch of the same product at a defined stage of manufacture should
be authorised beforehand. This recovery should be carried out in accordance with a
defined procedure after evaluation of the risks involved, including any possible effect
on shelf life. The recovery should be recorded.
5.69 The need for additional testing of any finished product which has been reprocessed, or
into which a recovered product has been incorporated, should be considered by the
Quality Control Department.
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5.70 Products returned from the market and which have left the control of the manufacturer
should be destroyed unless without doubt their quality is satisfactory; they may be
considered for re-sale, re-labelling or recovery in a subsequent batch only after they
have been critically assessed by the Quality Control Department in accordance with a
written procedure. The nature of the product, any special storage conditions it requires,
its condition and history, and the time elapsed since it was issued should all be taken
into account in this assessment. Where any doubt arises over the quality of the product,
it should not be considered suitable for re-issue or re-use, although basic chemical
reprocessing to recover active ingredient may be possible. Any action taken should be
appropriately recorded.
Product shortage due to manufacturing constraints
5.71 The manufacturer should report to the marketing authorisation holder (MAH) any
constraints in manufacturing operations which may result in abnormal restriction in the
supply. This should be done in a timely manner to facilitate reporting of the restriction
in supply by the MAH, to the relevant competent authorities, in accordance with its
legal obligations4.