TRS 1060 - Annex 3: WHO good manufacturing practices for excipients used in pharmaceutical products

Overview

The purpose of this document is to provide guidance for the production, control, storage and distribution of excipients used in pharmaceutical products, focusing on good manufacturing practices (GMP) under an appropriate system for managing quality. It is also intended to help ensure that such excipients meet the requirements for quality and purity that they purport or are represented to possess.
WHO Team
Access to Medicines and Health Products (MHP), Health Product Policy and Standards (HPS), Norms and Standards for Pharmaceuticals (NSP), Technical Standards and Specifications (TSS)
Number of pages
54