IQ, OQ, PQ in the Verification and Validation Process Training Course: Master V&V Planning Aligned With FDA cGMP, ICH Q-Series, ISO 13485, and ISO 14971 Risk Management (ONLINE ...

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, ...
Morningstar

Applied StemCell Announces Drug Master File Submission to the US FDA for their GMP-Grade iPSC Cell Line

Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.
BioTechniques

FDA 21 CFR Part 11 and the importance of regulatory compliance in GMP and GLP labs

The regulations for food and drugs in the United States, described in Title 21 of the Code of Federal Regulations (CFR), are critical in ensuring safe and ethical drug administration. Whether you are ...
Nasdaq

BIO-TECHNE ANNOUNCES SUBMISSION OF FDA DRUG MASTER FILE FOR EXCELLERATE GMP IPSC EXPANSION MEDIUM SUPPORTING STEM CELL THERAPY

MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...
Morningstar

Akadeum Life Sciences Announces Drug Master File Submission to the US FDA for GMP Microbubble Cell Separation

Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...