This guideline is intended to provide guidance to the applicants responding to the inspection report following a GMP, GWP or GCP inspection at their site. It is not intended as an exclusive approach leaflet and should not be taken as a complete or authoritative statement of the law.
SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine or medical device in keeping with the knowledge current at the time of evaluation. The SAHPRA is committed to ensure that all registered medicines or medical devices will be of the required quality, safety and efficacy and that the manufacturer/ wholesaler/ clinical trial site complies with acceptable quality assurance principles and good manufacturing/ wholesaling /clinical practices as determined by SAHPRA to manufacture, import or export, wholesale or conduct clinical trials.
It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications. The guidance in this Guidelines and application forms are available from the office of the CEO: SAHPRA and the website.
First publication for Implementation: November 2019_Document here.