Introduction Qualification of USP Elastomeric Closures serves as a regulatory cornerstone for verifying the material safety, chemical cleanliness, and biological […]
USP <381> Elastomeric Closures: What It Means for Stopper and Plunger Qualification Read More »
Introduction Physicochemical testing under USP , <661.1>, and <661.2> provides a standardized analytical framework for establishing the chemical safety, material
Introduction: Why Glucagon Generic Characterization Is Technically Demanding Glucagon Generic Characterization is demanding because glucagon is one of the least
Introduction Secondary and tertiary packaging leachables are volatile, semi-volatile, or mobile chemical substances that originate from non-contact outer packaging materials,
Introduction Extractables Testing of Sterilizing-Grade Filters involves evaluating chemical compounds that migrate from filter materials under exaggerated solvent, temperature, and
Introduction Under Section 351(k) of the Public Health Service Act (PHS Act), an abbreviated Biologics License Application (aBLA) for a
Introduction: The Nitrosation Assay Procedure (NAP Test) is an experimental approach for investigating the nitrosation potential of amine-containing active pharmaceutical
Introduction The FDA Purple Book is an online database that enables biopharmaceutical researchers and regulatory specialists to assess FDA-licensed Section
Introduction Qualifying plastic manufacturing equipment under USP and requires a structured, risk-based chemical characterization approach to ensure that organic extractables
USP <665> and <1665>: How to Qualify Plastic Components Used in Drug Manufacturing Read More »
Introduction Evaluating Process Equipment-Related Leachables (PERLs) under 21 CFR 211.65 is an essential compliance requirement for pharmaceutical and biopharmaceutical manufacturers
