Material defects case histories

Centrifugal pumps serve the industries well, but can be involved in accidents even if they are correctly sized and specified, made of the correct materials, and properly installed. Three pump incidents follow. This first case history involves an explosive incident that occurred during maintenance to remove a defective pump. Incidents two and three occurred during operations. 

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. 

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