Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has […]
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 […]
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 […]
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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