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 ...

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, ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...