Guide to Good Manufacturing Practice for Medicinal Products Part II - PIC/S, PE 009-8 (Part II), 15 January 2009. Developed by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
(2009; 55 pages)

Abrégé

This document (Guide) 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. In this Guide “manufacturing” includes all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls.

 
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