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/enterprise/pharmaceuticals/eudralex/homev4.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
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 Active Pharmaceutical Ingredients
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 Biotech
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