Luff P R
Veterinary Medicines Directorate, Addlestone, Surrey, UK.
Dev Biol Stand. 1992;79:155-8.
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.
生产控制集中于根据制造商提供的信息以及详细的实地检查对生产操作进行评估。控制生产的目的是在切实可行的范围内确保产品在符合一定标准的场所内，由符合一定标准的工艺和人员进行生产，从而保证最终产品的质量。所需标准载于《药品生产质量管理规范指南》及其若干补充指南，因此，实际上检查的目的是评估是否符合这些指南。然而，制造商的厂房和操作通常并非在所有方面都符合指南要求。因此，有必要对这些差异的重要性和相关风险作出判断。有必要在整个生产过程的背景下考虑潜在问题，同时牢记所涉产品的性质。然后决定需要采取何种补救措施以及在多长时间内采取这些措施。
