Manufacturing quality control design aspects

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 . 

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. 

Principle. The purpose of self-inspection is to evaluate the manufacturer s compliance with GMP in all aspects of production and quality control. The self-inspection program should be designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions. Self-inspections should be performed routinely, and may be, in addition, performed on special occasions, e.g., in the case of product recalls or repeated rejections, or when an inspection by the heath authorities is announced. The team responsible for seif-inspection should consist of personnel who can evaluate the implementation of GMP objectively all recommendations for corrective action should be implemented. The procedure for self-inspection should be documented, and there should be an effective follow-up programme. 

The CEGB as a prudent operator conducts a series of visual Inspections of reactor Internals on a biennial basis and these are listed In the Statutory Maintenance Schedule. The purpose of the Inspections Is to assist In providing confirmation of reactor system Integrity and Is complementary to other aspects such as conservative design, quality control during manufacture and material specimen monitoring. 

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. 

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