The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...
Safety and efficacy are the two regulatory benchmarks for pharmaceutical products. Microbial contamination of products is an important aspect of product quality that can affect both safety and ...
Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...
The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) - Seminar Materials" report has been added to Research and ...
Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...
Validation ensures that a part will operate correctly in end-user applications. Design validation is the task of testing a part or a system adequately to ensure that all parts or systems manufactured ...
Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...
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