What is GMP?

Good Manufacturing Practice (GMP) Resources

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.

https://ispe.org/initiatives/regulatory-resources/gmp

What is GMP

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been first-rate 20 years ago may be less than adequate by current standards.

https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp

GMP Regulations and Preambles

Australia

• Therapeutic Goods Administration

Canada

• Health Canada

• Submission Filing Requirements - Good Manufacturing Practices GMP/Establishment Licences (EL)

Guidance Documents

• Guidance Document Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals(3 March 2009)

• Medical Gas - Good Manufacturing Practices (GMP) Questions and Answers(July 2007)

• Good Manufacturing Practices (GMP) Guidelines - 2009 Edition (GUI-0001)

• GMP Questions and Answers

China

• China Food and Drug Administration

• Regulations for Implementation of the Drug Administration Law of the People's Republic of China

Europe

• European Medicines Agency

• Eudralex Volume 4 - Good Manufacturing Practice Guidelines

India

• Central Drug Standard Control Organization

• Schedule M - Good Manufacturing Practices and Requirements of Premises, Plant and Equipment For Pharmaceutical Products

Japan

• Japan - Pharmaceuticals and Medical Devices Agency

United States

• Food and Drug Administration GMP Regulations

• 21 CFR Part 4 - Current Good Manufacturing Practice Requirements for Combination Products (As of 1 April 2013)

• 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs (As of 1 April 2013)

• 21 CFR Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals- (As of 1 April 2013) Historical preambles announcing changes and comments regarding 21 CFR Parts 210 and 211.

• 21 CFR Part 212 Current Good Manufacturing Practice for Positron Emission Tomography Drugs - (As of 1 April 2013)

• 21CFR Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (As of 1 April 2013) Historical preambles announcing changes and comments regarding 21 CFR Part 110

• 21 CFR Part 606 - Current Good Manufacturing Practice For Blood and Blood Components (As of 1 April 2013) Historical preambles announcing changes and comments regarding 21 CFR Part 606

• 21 CFR Part 820 - Quality System Regulation (As of 1 April 2013) Historical preambles announcing changes and comments regarding 21 CFR Part 820

• 21 CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (As of 1 April 2013) Historical preambles announcing changes and comments regarding 21 CFR Part 111

World Health Organization (WHO)

• World Health Organization

• WHO Good Manufacturing Practices

https://ispe.org/initiatives/regulatory-resources/gmp/regulations

World Health Organization Guidelines

Quality Assurance of Pharmaceuticals -

A Compendium of Guidelines and Related Materials

https://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf

Center For Device and Radiological Health

Guidance Documents

Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the practical, "real world" information you need to help your company build on current best practices to meet and exceed regulatory standards.

https://ispe.org/publications/guidance-documents#

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