TRS 1044 - Annex 2: WHO good manufacturing practices for sterile pharmaceutical products

Annex 2, WHO Technical Report Series 1044, 2022

Overview

This document is a revision of WHO good manufacturing practices for sterile pharmaceutical products, previously published in the WHO Technical Report Series, No. 961, Annex 6, 2011.1 The revision was done in collaboration with the European Union and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The harmonized text will benefit the national regulatory authorities and manufacturers and save resources, thus improving patients’ access to quality medicines.

 

 

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)