This guideline is intended to provide guidance to the applicants responding to the inspection report following a GMP, GWP, GCP, GVP, inspection at their site.
This document has been prepared as a guide to assist applicants to comply with the requirements for Site Master Files with regard to all sites for pharmaceutical business.
This document has been prepared to serve as a recommendation to applicants wishing to conduct business as medicine wholesalers.
The objective of this procedure is to define the process to be followed and to provide instruction to the Holder of the Certificate of Registration (HCR) when submitting an application for Post-Importation Testing Exemption or imported products.
This document is intended to serve as guidance on the requirements for Good Manufacturing Practice (GMP) in South Africa. This guideline is not intended as an exclusive approach.