Validation (drug manufacture)
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High Quality Content by WIKIPEDIA articles! 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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GarantieWeitere Informationen
- Allgemeine Informationen
- Sprache Englisch
- Editor Lambert M. Surhone, Miriam T. Timpledon, Susan F. Marseken
- Titel Validation (drug manufacture)
- ISBN 978-613-0-31713-3
- Format Fachbuch
- EAN 9786130317133
- Jahr 2009
- Größe H220mm x B4mm x T150mm
- Untertitel GxP, Good Manufacturing Practice, Good Automated Manufacturing Practice, Verification and Validation
- Gewicht 113g
- Genre Medizin
- Anzahl Seiten 72
- Herausgeber Betascript Publishers
- GTIN 09786130317133
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