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GMP News

13.11.2025

Proposed Revision of USP <1225> Published in the Pharmacopeial Forum

In the Pharmacopeial Forum, PF 51(6), a proposed revision of USP General Chapter <1225> has been published. The revision includes a title change from "Validation of Compendial Procedures" to "Validation of Analytical Procedures", reflecting the broader applicability of the chapter to both compendial and non-compendial analytical procedures.

13.11.2025

FDA Warning Letter to U.S.-based OTC Manufacturer: Deficiencies in Release Testing, Raw Material Controls and Stability Program

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Michigan-based OTC manufacturer due to significant CGMP violations, including missing release testing, insufficient raw material controls, and inadequate stability studies.

13.11.2025

Recent Publications Highlighting Topics to be Discussed at PharmaLab 2025

In the run-up to PharmaLab 2025 in Neuss from 24 to 26 November, several articles have been published that provide insights into current developments and discussions in the field of analytical quality control.

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