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Validation Compliance Biannual 1996-1997
International Validation Forum
出版CRC Press, 1996-04-10
主題Science / Chemistry / GeneralMedical / Pharmacology
ISBN08247974699780824797461
URLhttp://books.google.com.hk/books?id=tzhMkBPc-3gC&hl=&source=gbs_api
EBookSAMPLE
註釋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.