GMP Regulations/Guidelines - International Countries

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)

A Guide to Good Manufacturing Practice (GMP) Requirements. Part 1: Standard operating procedures and master formulae

WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation

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

Australia

Australian Code of Good Manufacturing Practice for Medicinal Products

Based on PICS, August 2002

Questions & answers on the Australian code of good manufacturing practice for medicinal products

Canada

Guidelines for Cleaning Validation

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

FDA Regulations

21 CFR Part xxx