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 publishes guidelines on topics concerning safety, quality, efficacy, and multidisciplinary topics.
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 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.