cGMP Links
This is a collection of links we have found useful:
Regulations
Government Authority sites
Eudralex - European cGMP
GAMP (ISPE)
International Conference on Harmonization (ICH)
International Organization for Standardization (ISO)
US Code of Federal Regulations (CFR)
WHO GMP
European Medicines Agency (EMEA)
Pharmaceuticals and Medical Devices Agency, Japan
Swedish Medical Products Agency
US Food and Drug Administration (FDA)
Pharmacopoeias
Useful links
British Pharmacopoeia (BP)
European Pharmacopoeia (Ph.Eur.)
International Pharmacopoeia, WHO
Japanese Pharmacopoeia (JP)
United States Pharmacopoeia (USP)
FDA's Inspections Operations Manual
FDA Warning Letters
FDA Guidance Documents
21 CFR Part 11
Pharmacopeial Forum (USP)
Svensk Läkemedelsstandard 2009.1 (SLS)
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