Transcription of MEDICINES CONTROL COUNCIL - mccza.com
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MEDICINES CONTROL COUNCIL - mccza.com
SA Guide to GMP. MEDICINES CONTROL COUNCIL . GUIDE TO good manufacturing PRACTICE. FOR MEDICINES IN SOUTH AFRICA. This document has been prepared to serve as a guidance document on the requirements for good manufacturing Practice applicable to the manufacturing of MEDICINES . It is not intended as an exclusive approach. COUNCIL reserves the right to request for any additional information to establish the safety, quality and efficacy of a medicine and may make amendments in keeping with the knowledge which is current at the time of consideration of data accompanying applications for registration of MEDICINES .
PE 0092 dated - 1 July 2004 published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The modifications to that Guide and its adoption as the South African Guide to Good Manufacturing Practice is done so with the expressed permission of the PIC/S.
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