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Good Manufacturing Practice (GMP) Regulations and Guidelines

EU GMP Related Directives

 

Directive 2001/83
The EU Community Code for Human Medicinal Products
Directive2001/20 The EU Clinical Trials Directive
Directive 2003/94 The EU GMP Directive

 

Other EU Legislation/Guidance

EMA Human Medicines EU Information for Human Medicines
Eudralex EU Legislation for Medicinal Products
Eudralex Pharma Section EU Pharmaceuticals Information
Eudralex Volume 1 - Legislation Human EU Legislation for Human Medicinal Products
Eudralex Volume 3 - Guidelines Human EU Scientific Guidelines for Human Medicinal Products
Eudralex Volume 4 - GMP Human and Veterinary EU GMP Guidelines for Human and Veterinary Medicinal Products
Good Distribution Practice Guideline on Good Distribution Practice
Mutual Recognition Agreements (MRAs) Information on Mutual Recognition Agreements between EU and Non-EU Countries
   

 

MHRA Legislation/Guidance

UK Medicines Act 1968 UK Legislation on Medicines
Licensing of Medicines Information on Licensing of Medicines in the UK
UK GMP Information on UK GMP
UK Guidance Notes UK Guidance Notes for Medicines
GMP Q&A MHRA Frequently Asked Questions on GMP
UK S2012/1916 The Human Medicines Regulations 2012

 

US Legislation/Guidance

CFRs US Legislation on Food, Drugs and Cosmetics
FDA Investigations Operation Manual Guidance on FDA Inspections - General
FDA Inspection Guides Guidance on FDA Inspections - Specific Topics
FDA CBER Guidance/Guidelines/Points to Consider FDA Guidances and Regulatory Information for Biologics
FDA CDER Guidances FDA Guidances and Regulatory Information for Drug Products
FDA Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing Current GMP US Guidance on Requirements for Aseptically Manufactured Drug and Biological Products

 

MHRA Good Manufacturing Practice: The Inspection Process

Click here to view the process which covers planning, types of inspection, notification, conduct, definition of deficiencies, post-inspection letter, referal to Inspection Action Group, company responses and inspection report.

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