International GMP Resources

Print this page         

International Conference on Harmonization

  • Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs)
    This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.
  • ICH Guidelines
    ICH publishes guidelines on topics concerning safety, quality, efficacy, and multidisciplinary topics.

PIC/S

  • PIC/S GMP Guide products
    Guidelines to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products, the Guide to Good Manufacturing Practice for Medicinal Products and its Annexes has been adopted.
  • PIC/S Guidelines
    PIC/S publishes a variety of guidelines on GMP and other topics.

World Health Organization

  • WHO GMP page
    This page provides WHO's GMP standards and guidelines for a variety of products.
Last Update: 19 September 2011

My ISPE

  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile
Click to go to the Member Gift