![]() ![]() When acceptable evidence of GMP compliance is not available, overseas manufacturers are inspected by the GMP Inspectorate before registration of the medicine is approved.The Act requires that overseas manufacturers of medicine supplied to South Africa should comply with the same or equivalent manufacturing standards as expected of South African manufacturers. ![]() Under Section 22C of the Act, all South African manufacturers should be licensed.Medicines Control Council’s (MCC) general policy is that the standard to be used to assess compliance with current Good Manufacturing Practice (cGMP), is the South African Guide to Good Manufacturing Practice (SA guide to GMP). The Manufacturer and Holder of Certificate of Registration, where different, should evaluate the results of the review and an assessment should be made of whether corrective and preventative action or any revalidation should be undertaken. ![]()
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