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A recent FDA Warning Letter reveals severe GMP breaches at a U.S. drug manufacturer, including the absence of written procedures, reliance on undocumented processes, and a failure to perform basic analytical testing such as identity, strength, and microbiological checks prior to product release.

The Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", which was prepared jointly by the EMA and the CMDh, has been updated once again and published in the new revision 22 on the EMA website.

The guideline 'Additional guidance on the assessment on the risk assessment for presence of N-nitrosamines in APIs', first published in February 2020, has now been revised by a subgroup of the 'APIC Nitrosamines Task Force' and recently published in its latest version on the APIC website. The document is now called 'Nitrosamine Risk Management: Guidance for API Manufacturers' and has been extensively updated.

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.