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 : RegistrationManufacturing  &  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

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