Good Manufacturing Practice (GMP) Regulations and Guidelines

EU GMP Related Directives

 

Directive 2001/83

The EU Clinical Trials Regulation

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines

 

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.