Manufacturing quality assurance design aspects

For all products in Classes Ila, lib and III, and AIMDs, a full quality assurance system, audited periodically by a notified body (Annex II of the MDD), which includes examination and certification by the notified body of the design dossier of each product covered. The manufacturer must keep documentation on the quality system and the design dossier of each product plus other documentation. The quality system obligations include post-marketing and vigilance aspects. Compliance with Annex II may be achieved (this is not mandatory but is invariably adopted voluntarily) by compliance with the EN 29000... 

Principle. Good documentation is an essential part of the quality assurance system and, as such, should be related to all aspects of GMP. Its aims are to define the specifications for all materials and methods of manufacture and control, to ensure that all personnel concerned with manufacture know what to do and when to do it, to ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale, and to provide an audit trail that will permit investigation of the history of any suspected defective batch. The design and use of documents depend upon the manufacturer. In some cases some or all of the documents described below may be brought together, but they will usually be separate. 

First part qualification. First part qualification is a process performed the first time a new bonded assembly is manufactured or the first time a new tool is used to manufacture a bonded assembly. First part qualification provides assurance that all of the aspects that control bond assembly quality, such as the design dimensions, detail part manufacturing techniques, tool dimensions, layup procedures and autoclave cure cycle parameters are correct and will produce a bond assembly that meets the engineering requirements. 

All stages of antibiotic manufacture from fermentation through to finished product are governed by the code of good manufacturing practice (GMP), of which quality control is one aspect. GMP requires that there should be a comprehensive system, so designed, documented, implemented and controlled, and so furnished with personnel, equipment and other resources as to provide assurance that products will consistently be of a quality appropriate to their intended use . 

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