Control of manufacture--principles and purposes.

The control of manufacture is centred on the assessment of the operation based on information supplied by the manufacturer and on detailed physical inspection. The purpose of controlling manufacture is to ensure, as far as practicable, that products are manufactured within premises, and by processes and personnel, of such standard that the quality of the final product is assured. The required standards are written in the "Guide to Good Manufacturing Practice for Medicinal Products", and its several supplementary guidelines, so in practical terms the purpose of inspection is to assess compliance with these guidelines. It is usual, however, for manufacturers' premises and practices not to comply with the guidelines in all respects. There is therefore a need to make judgements on the significance of, and risks associated with, these discrepancies. It is necessary to consider potential problems in the context of the overall manufacturing process, bearing in mind the nature of the products involved. A decision as to what remedial actions are required, and over what time-scale, is then made.