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The U.S. Food and Drug Administration criticises the handling of Out-of-Specification (OOS) results in a recent Warning Letter. Insufficient root cause analyses, premature retesting, and missing effectiveness checks of CAPAs are at the centre of the agency’s concerns. The case once again underlines the regulatory relevance of a robust and scientifically sound OOS management system.

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Appendix 1 of the nitrosamine 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' from the EMA/CMDh was updated in December 2025.

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The FDA issued a new Warning Letter citing critical CGMP violations at a U.S. OTC manufacturer, including gaps in benzoyl peroxide testing, stability programs, quality unit oversight, and the failure to execute a recall despite confirmed benzene contamination.

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Excel spreadsheets remain widely used in GMP-regulated environments, but without adequate controls they pose significant data integrity risks. This news item refers to an FDA Form 483 in which investigators identified fabricated Excel-based production records, deleted electronic files, and duplicate log books, highlighting the importance of robust spreadsheet governance for GMP-compliant data integrity systems.

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The U.S. Food and Drug Administration has issued a Warning Letter to an API manufacturing site in India. Since 2023, approximately 1,500 laboratory incidents (including OOS results and major analytical events) have been recorded, and the authority identified systemic failures in the handling of Out-of-Specification (OOS) results, laboratory investigations, and the overall CAPA system.

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In November and December 2025, the ‘Questions & Answers (Q&A)’ document ‘European Medicines Agency post-authorisation procedural advice for users of the centralised procedure’, which addresses topics that may be relevant after marketing authorisations has been granted, was updated and published on the website of the European Medicines Agency (EMA).

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In October 2025, the 'Questions & Answers (Q&A)' document relating to topics before and during the application process - 'European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure' - was updated again and published on the website of the European Medicines Agency (EMA).

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Conducting GMP audits is an essential tool for monitoring and continuously improving pharmaceutical quality systems. But what are the requirements?

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During an inspection in spring 2025, the FDA identified serious violations of GMP requirements at a US manufacturing facility for topical OTC medicines. The FDA deemed the response letter submitted to be insufficient, as it did not provide any reliable evidence or specific corrective measures.

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In October 2025, the Q&A document "Questions and answers for marketing authorization 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 jointly created by the EMA and the CMDh, was updated and published in the new Revision 23 on the EMA website.

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