SA Guide to Good Manufacturing Practice for Medicines

This document provides guidelines for the requirements of Good Manufacturing Practice (GMP) in South Africa. This guideline is not an exclusive approach. SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine. SAHPRA may amend this guideline in keeping with the latest knowledge at the time of consideration of data accompanying applications for registration of medicines. Scientifically and technically justified alternative approaches SAHPRA is committed to ensuring that all medicines gaining market approval will be of the required quality, safety and efficacy standards.