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Use Statistical Thinking and Methods to Make Better Decisions – Dr. Ron Snee

Ronald D Snee. PhD, Snee Associates, LLC, Newark, DE 19711The scientific method is fundamental to the operation and success of the pharmaceutical industry including the discovery of new products, development of the products using clinical trials and the manufacture of the products. The scientific method has three key components:Recognition and formulation of a problem Collection […]

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White Paper: Human Contamination and Controlled Access in Clean Room Environments – Compliance with Annex 1, Paragraph 7.2

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 […]

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Flowchart – Analytical Lifecycle Approach

Created by: Jennifer Lewis, Ph.D., Director, University of Rhode IslandICH-Q14_Takeaway-Tool-(Laboratory University)Download

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An Overview of Experimental Designs in HPLC Method Development and Validation

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 […]

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Validation Of Analytical Methods In A Pharmaceutical Quality System: An Overview Focused on HPLC Methods

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 […]

Category: Article

Use Statistical Thinking and Methods to Make Better Decisions – Dr. Ron Snee

White Paper: Human Contamination and Controlled Access in Clean Room Environments – Compliance with Annex 1, Paragraph 7.2

Flowchart – Analytical Lifecycle Approach

An Overview of Experimental Designs in HPLC Method Development and Validation

Validation Of Analytical Methods In A Pharmaceutical Quality System: An Overview Focused on HPLC Methods

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