Presenter:Kim Huynh-Ba, M.S., FAAPS, Managing Director, Pharmalytik LLC; Adjunct Faculty, RAQA Program, Temple UniversityOverview:– Review current regulatory expectations for Data Integrity– Spot common lab data issues and how to avoid them– Strengthen documentation and record keeping practices– Improve system controls and data security measures– Promote a culture of accountability and data ownership To access this post, […]
By Jane Weitzel, Quality Control Expert, and USP Council of Experts Member & Chair of the 2020-2025 General Chapters –Measurement and Data QualityFit for intended purpose is a key, central concept for USP <1220> Analytical Procedure Life Cycle, ICH Q2(R2) Validation of Analytical Procedures, and ICH Q14 Analytical Procedure Development. The performance criteria for the […]
Kim Huynh-Ba*, Pharmalytik LLC, and Christopher Latoz, Hollister Incorporated*Corresponding Author: kim.huynhba@pharmalytik.comAbstractPharmaceutical products require expiration dates and storage conditions on their labels, determined through stability studies conducted from clinical trials through post-approval. These studies ensure that any chemical, physical, or microbiological changes over time do not affect the product’s quality, safety, or efficacy. ICH Q1A(R2) provides […]
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 […]
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