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GMP News

USP informs about Monographs affected by the Revision of NMR Chapters <761> and <1761>

Revisions to USP Chapters <761> Nuclear Magnetic Resonance Spectroscopy and <1761> Nuclear Magnetic Resonance Spectroscopy—Theory and Practice were proposed for comment in PF 49(5) and are scheduled to become official on 1 December 2025. The USP has now identified other documentary standards that reference these chapters and has published a list of monographs that will be revised accordingly.

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Root Cause Investigations criticised at EU Company

A Warning Letter was issued to a Dutch company, also because root cause determinations and CAPAs were deemed inadequate.

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Warning Letter to Chinese Manufacturer due to serious Sterility and Hygiene Deficiencies

The FDA found serious GMP deficiencies during an inspection of a Chinese pharmaceutical manufacturer in November 2024. These include, above all, inadequate hygiene and ensuring the sterility of the products. For example, medicinal products were labelled as 'sterile' although neither sterilisation nor sterility tests were carried out.

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