GUIDELINES

IMPORTANT GUIDELINES
REGULATORY GUIDELINES - SUMMARY PAGES - ONE STOP POINT
CERTIFICATE OF SUITABILITY (CEP)
PACKING AND LABELING
WEBSITES FOR INTERNATIONAL REGULATORY GUIDELINES
USFDA - Guidances (Drug)	Pharmaceutical Inspection convention -Guides
EudraLex The Rules Governing Medicinal Products in the European Union	APIC Publication
Health canada - Guidance Documents	Health canada - Validations
Health canada - GMP - Questions and Answers	Health canada - Good Clinical Practices
Health canada - Good Clinical Practices - Guidance Documents	WHO Quality Assurance Guidelines
WHO - Publications - Technical Reports	Health Sciences Authority : Registration, Manufacturing  &  Regulatory
Therapeutic Goods Administration	SFDA, China - Regulatory Guide
PDMA, Japan - Regulations and Procedures	Regulations & Guidelines - Indian Pharmaceutical Association
Singapore Drug Registration Information and Guidelines	Health Sciences Authority, Singapore- Regulatory Guidance
Regulations & Guidelines - Saudi Arabia Food and Drug Authority.	Guidelines of different countries - Consolidated - BEBEC
IMPORTANT GUIDELINES
Technical guide for the elaboration of monographs – 6th Edition (2011)	European Pharmacopoeia Style Guide, July 2008
Guide to the Graphic Representation & Nomenclature of Chemical Formulae in the European Pharmacopoeia, 1st Edition 2006	How to do" - Interprétation of ICH Q7 document & "Review Form (update May 2011)
Camparability Protocol	Cleaning Validations - APIC
The Drugs and Cosmetics Act and Rules - India	Schedule - M
Guidelines for Bioavailability and Bioequivalence studies - India	Schedule - L1