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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)

Europe

 

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

http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

 

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

 

Canada

 

Guidelines for Cleaning Validation

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

 

FDA Regulations

21 CFR Part xxx