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 […]