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EU GMP Websites

Agencies Europe for Human Medicines
APIC GMP Guidelines for Active Ingredients
EU GMP Guidelines Eudralex Vol. 4
EMEA Human Medicine Guidelines
EDQM Certification Guidelines

US GMP Websites

US FD&C Act
US CFR Titles Overview
US Federal Regulations & Comments
US Federal Register Documents - FDA
US FDA Guidances General
US FDA Guidance for Drugs
US FDA Guidance for Biologics
US FDA Guide to inspections of
US FDA Compliance Program Guidance Manual (CPGM)
US FDA Compliance Policy Guidance Manuals (CPG)
US FDA Manufacturing according GMP
US FDA Questions & Answers on cGMP

International GMP Websites

PIC/S GMP Guides
ICH GMP guideline
WHO Documents online
WHO Documents on Quality Assurance
WHO GMP Production Guidelines
WHO GMP Training Material
WHO Technical Report Series
WHO Codex Alimentarius

Pharmacopoeia Websites

WHO International Pharmacopoeia
WHO Index List of Pharmacopoeias
USP US Pharmacopoeia
EP European Pharmacopoeia
BP Britisch Pharmacopoeia
JP Japanese Pharmacopoeia
IP Indian Pharmacopoeia

Other useful Websites

Australian GMP Guidelines
Canadian GMP Guidelines
Chinese SFDA
Indian Central Drugs Standard Control Organization
Japanese Ministry of Health, Labour and Welfare
Korean KFDA



gemro Services ltd.
Address: Rms. 1106-7,
Kowloon Centre, 29-43
Ashley Rd., Tsim Sha Tsui,
Kowloon, Hong Kong
Tel: (852) 2317 5988
Inquiry: (86) 20-8736 5457
info@gemro-services.com

 
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