Jason Carter, jcarter@nav-team.com, Nav-Team, Inc.AbstractThe critical issue of human contamination in clean room environments, with a focus on compliance with Annex 1, Paragraph 7.2, of the European Union Guidelines to Good Manufacturing Practice (GMP). Personnel represent a significant contamination risk in sterile manufacturing, introducing both viable and non-viable particles into controlled environments. Annex 1 mandates […]
Created by: Jennifer Lewis, Ph.D., Director, University of Rhode IslandICH-Q14_Takeaway-Tool-(Laboratory University)Download
Created by: Prafulla Kumar Sahua, Nageswara Rao Ramisetti b,∗, Teresa Cecchi c,∗, Suryakanta Swaind,Chandra Sekhar Patroa, Jagadeesh PandaChemometric approaches have been increasingly viewed as precious complements to high performanceliquid chromatographic practices, since a large number of variables can be simultaneously controlledto achieve the desired separations. Moreover, their applications may efficiently identify and optimizethe significant factors […]
Created by: Breno M. Marsona, Victor Concentinoa, Allan M. Junkerta, Mariana M. Fachia, Raquel O. Vilhenaa and Roberto PontaroloAnalytical validation has fundamental importance in the scope of Good Manufacturing Practice (GMP) for pharmaceutical products since it establishes scientific evidence that an analytical procedure provides reliable results. However, even with validation guidelines available it is very […]
Created by: Ronald D. Snee, PhD, Snee Associates, LLCSnee-QbDTestMethodDevelopment-Pharm-ProcessingFeb2014Download
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