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When out-of-specification (OOS) laboratory results are explained rather than thoroughly investigated, and HPLC methods are not demonstrably fit for purpose, regulatory action may follow. A recent FDA Warning Letter highlights how recurring weaknesses in OOS handling and analytical method validation can result in significant CGMP compliance risks.

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In October 2025, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published version 3 of the document 'Data Integrity Frequently Asked Questions (FAQ)' on its website. In the new version, 'Chapter 5. Record life cycle management:' has been updated.

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The subject line asks whether a change in the ownership of a pharmaceutical manufacturer could affect GMP compliance. According to the FDA, the answer is yes.

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Since December 2025, the first version of the 'Quality Agreement Template for Regulatory Starting Materials ('RSMs') and Critical Materials between company 'x' and company "y"' has been available on the APIC website under the 'Publications' tab. This first version, which according to the document history is dated September 2025, was initially created by the APIC Task Force 'Supplier Management' and is based on the APIC Guidance Document 'APIC Quality Agreement Guideline & Template'.

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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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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 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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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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