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 . Alternative approaches may be used but these must be scientifically and technically justified. The MCC is committed to ensure that all MEDICINES gaining market approval will be of the required quality, safety and efficacy.
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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