Validation Compliance Biannual 1996-1997

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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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목차

Preface
1
Government Regulation
28
Situational Review
207
Appendices
297
Tools for Validation
347
Field Findings
721
Future Developments
737
Index
842
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