TRS 957 - Annex 2: WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug substances)

This document (guide) is intended to provide guidance regarding good manufacturing practices (GMP) for the  manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system formanaging 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” is defi ned to include all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls. In this guide the term “should” indicates recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance. For the purposes of this guide, the terms “current good manufacturing practices” and “good manufacturing practices” are equivalent.