News about GMP/cGMP

01.07.2022

FDA: Draft on Contamination Prevention for Non-Penicillin Beta-Lactam Drugs

FDA: Draft on Contamination Prevention for Non-Penicillin Beta-Lactam Drugs

The FDA issued a draft guidance outlining a framework of methods, designs and controls for preventing cross-contamination of non-penicillin beta-lactam antibacterial drugs and compounds, which serves as an update for a 2013 guidance with the same title. (Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination; Draft Guidance for Industry; Availability).


The new draft guidance also contains FDA recommendations for CGMP requirements on preventing cross-contamination of these products, including the separate manufacturing of non-penicillin beta-lactam antibacterial drugs from other drug manufacturing processes, as well as alternate recommendations when complete separation of manufacturing is not possible.

Public comment is open until 23 August 2022.


Sources:

RF Regulatory Focus: News

US Federal Register: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination; Draft Guidance for Industry; Availability

 


 

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