TRS 961 - Annex 14: WHO guidelines for drafting a site master file
Annex 14 - WHO Technical Report Series 961
31 October 2011
| Technical document
Overview
The aim of these explanatory notes is to guide the manufacturer of medicinal products in the preparation of an SMF that is useful to the regulatory authority in planning and conducting GMP inspections.
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
8