Validation Compliance Biannual 1996-1997CRC Press, 10/04/1996 - 856 páginas 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. |
Índice
Preface | 1 |
Government Regulation | 28 |
Situational Review | 207 |
Appendices | 297 |
Tools for Validation | 347 |
Field Findings | 721 |
Future Developments | 737 |
| 842 | |
Palavras e frases frequentes
activities adequate adverse events agency analysis and/or anti-HIV antibody appropriate approval audit automated biological blood establishments CANDA system CBER Center certification changes clinical collection compliance components criteria dBase determine Division donor dose drug application drug product effective efficacy electronic ensure equipment Evaluation facility Failure FDA's Federal firm firm's FIS file GALPS GMP violations guidance documents guidelines identified informed consent inspection intended investigator Investigator's Brochure issued labeling laboratory licensed listed Lotus Agenda manual Manufacturing Practice medical devices Memorandum microcomputers notified Office operating paragraph patient performance person plasmapheresis premarket procedures protocol quality assurance recommended records red blood cells referred regulation regulatory response safety sample Secretary Source Plasma specific sponsor standards statistical submission submitted testing tion trial United validation VAXcluster venipuncture Warning Letter WordPerfect