Validation (drug manufacture)
GxP, Good Manufacturing Practice, Good Automated Manufacturing Practice, Verification and Validation
Please note that the content of this book primarily consists of articles available from Wikipedia or other free sources online. Validation in the pharmaceutical and medical device industry is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements. The concept of validation was first proposed by two Food and Drug Administration officials, Ted Byers and Bud Loftus, in the mid 1970's in order to improve the quality of pharmaceuticals. It was proposed in direct response to several problems in the sterility of large volume parenteral market.
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