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GMP News

23.04.2025

OTC Drug Production Ceased after FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter following an inspection that uncovered serious GMP deficiencies in the manufacturing of an OTC drug product, including missing release testing, lack of stability data, and inadequate quality oversight.

23.04.2025

New WHO Guideline Package: TRS 1060 published

The WHO published its latest Technical Report Series (TRS) 1060 in March. Among other things, the document contains new guidelines on the control of nitrosamines, on GMP for excipients, on bioanalysis as well as on the validation of bioanalytical methods. Regulations on simplified authorisation ('biowaiver') and on cooperation with national authorities as part of the WHO prequalification programme have also been updated and supplemented.

23.04.2025

Data Integrity Violations at an OTC Manufacturer

During an inspection, the US FDA found significant violations in the area of data integrity and documentation at a manufacturer of OTC drugs in Thailand. The violations identified relate to incomplete laboratory data, manipulated records and inadequate control of electronic systems.

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