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GMP Regulations/Guidelines - International Countries

Pharmaceutical Industry is challenged with many national and international regulations and guidelines. On this site you can find most important documents related to pharmaceutical manufacturing. They include GMPs from Europe and Australia but also from International Organizations such as PIC/S, ICH and WHO.

ICH - International Conference for Harmonization


ICH Q6A Guide

Good Clinical Practice

May 1996


Q6A: Specifications:

Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

December 2000


ICH Q7A Guide for Industry

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

December 2000


Q8 Guide

Pharmaceutical Development



Q9 Guide

Quality Risk Management



Q10 Guide

Pharmaceutical Quality Systems

May 2007 (draft)



EU GMP Directive

The rules governing medicinal products in the European Union

Volume 4, Good manufacturing practices

Medicinal products for human and veterinary use

To view and download the individual chapters and annexes



Annex 11 of EU GMP

Computerized Systems

Requirements are somewhat similar as 21 CFR part 11


Annex 15 of EU GMP

Validation and Qualification

Master plan, DQ, IQ, OQ, PQ, Equipment and Processes


European Pharmacopoeia

Distributed through EDQM

(European Directorate for the Quality of Medicines and Healthcare)


European Medicines Agency (EMEA)

Procedure for Coordinating Preauthorization GMP and Product/Process Related Inspections


European Medicines Agency (EMEA)

Note for Guidance for Start of Shelf Life of the Finished Dosage Form

Annex to Note for Guidance for Manufacture of the Finished Dosage Form


EU Directive 2001/20/EC

Good Clinical Practice

On the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use


EU Directive 2001/83/EC

On the Community Code Relating to Medicinal Products for Human Use

World Health Organization


Good Manufacturing Practices for pharmaceutical products: main principles
(TRS 908, Annex 4)


Active pharmaceutical ingredients (bulk drug substances)


Sterile pharmaceutical products (TRS 902, Annex 6)


Inspections of pharmaceutical manufacturers (TRS 902, Annex 7)


Quality system requirements for national GMP inspectorates (TRS 902, Annex 8)


Guidance on GMP inspection (TRS 908, Annex 6)


Model Certificate of GMP (TRS 908, Annex 5)


Final Draft: Good manufacturing practices: Updated supplementary guidelines for the manufacture of herbal medicines.


Validation of analytical procedures use in the examination of pharmaceutical materials (TRS 823, Annex 5)


Provisional guidelines on the inspection of pharmaceutical manufacturers (TRS 823, Annex 2)


GMP Question and Answers


Good Distribution Practices for Pharmaceutical Products (draft)



WHO Expert Committee on Specifications for Pharmaceutical Preparations

PIC/S - Pharmaceutical Convention Inspection Scheme


Pharmaceutical Inspection Convention Scheme (PICS) Publications

GMP, API, Master Plan, Computerized Systems

Click on Publications


Guide to Good Manufacturing Practice for Medicinal Products


PIC/S GMP Guide for Validation of Aseptic Processes


Recommendation on Quality System Requirements for Pharmaceutical Inspectorates


PIC/S Guidance on Good Practices for Computerised Systems in Regulated "GXP" Environments


Aide Memoire on Inspection of Quality Control Laboratories


Aide Memoire on Inspection of Biotechnology Manufacturers 


Aide Memoire on Inspection of APIs




Guidelines for Cleaning Validation

U.S. FDA - United States Food and Drug Administration


FDA Regulations

21 CFR Part xxx