PharmTech

Requirements for Electronic Records Contained in 21 CFR 211

The author discusses the regulatory requirements for electronic records contained in Title 21 CFR Part 211 and how they overlap with the requirements set forth in Title 21 CFR Part 11. FDA Title 21 ...
Business Insider

I Peace's cell manufacturing facility "Peace Engine Kyoto" receives third-party certification as US cGMP compliant: the facility now meets the standard for both the US and ...

PALO ALTO, Calif., May 25, 2021 /PRNewswire/ -- I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up focusing on Nobel Prize-winning technology "induced pluripotent stem cells (iPSCs)" ...
PharmiWeb

3 Common Violations of Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals and How to Prevent Them

Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This ...
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 ...
Seeking Alpha

Perspective Therapeutics Acquires CGMP-Compliant Manufacturing Facility

SEATTLE, March 05, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment ...