Statistical Tools for Development and Control of Pharmaceutical Processes: Statistics in the FDA Process Validation Guidance.
The recent US Food and Drug Administration Process Validation Guidance has provided clear statements on the need for statistical procedures in process validation. FDA has redefined validation to include activities taking place over the lifecycle of product and process-from process design and develop...
| Publicado en: | Journal of Validation Technology (JVT) Vol. 20; no. 1; pp. 1 - 7 |
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| Autor principal: | |
| Formato: | Journal Article |
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Institute of Validation Technology
Mar2014
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| Acceso en línea: | Ver este registro en EBSCOhost |