Validation Compliance Biannual 1996-1997
CRC Press, 1996. 4. 10. - 856페이지
This biannual offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries. It addresses significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories. It examines Good Manufacturing Principles (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), Good Automated Library Practices (GALPs), and others, and elucidates up-to-the-minute industry changes and international concerns.
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acceptable action activities addition adequate adverse agency analysis and/or application appropriate approval assure authorized blood CANDA CBER Center certification changes clinical collection complete compliance components conducted considered contain copy corrections described determine device Directive Division document donor drug effective electronic ensure equipment established Evaluation example Failure firm guidance guidelines identified important indicate individual inspection intended issued labeling laboratory Letter licensed limited listed maintain manufacturer measures medical devices meet methods necessary notice Office operating paragraph patient performance period person Plasma practices procedures reasonable received recommended records referred regulation regulatory response safety sample Secretary Source specific sponsor standards statistical submission submitted testing tion trial United validation written