Analytical Quality Control News

FDA Warning Letter Criticises Handling of OOS Results at a Contract Laboratory

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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FDA Warning: No Recall Conducted Despite Confirmed Benzene Impurity

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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CMDh/EMA: Update to Appendix 1 for Nitrosamines

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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Questions and Answers on System Suitability Tests (SST) - Part 1

During the ECA Live Online Training “System Suitability Tests (SST) and Troubleshooting for HPLC Methods” on 04 November 2025, a number of interesting and practice-oriented questions were raised by the participants. These questions have been answered in writing by the speakers’ team after the event. To share some of the key insights with a broader audience, we have compiled a selection of these Q&As. Read Part 1 here.

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PharmaLab 2025: Brief Summary of AQCG Track - Save the Date for 2026!

PharmaLab 2025 took place from 24 to 26 November in Neuss, featuring nine parallel conferences and two pre-conference workshops with more than 100 presentations. This year, the ECA Analytical Quality Control Group (AQCG) organised a one-day conference track entitled “Analytical Quality and Lifecycle Concepts”. Moderated by Dr Christopher Burgess (AQCG Chairman), the track comprised a series of presentations and discussions.

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FDA Form 483: Excel-Based Data Falsification and Duplicate Log Books

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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Become a Speaker at PharmaLab 2026 - Analytic, Bioanalytic, Microbiology

PharmaLab 2026 - become a speaker at the leading congress on analytics, bioanalytics and microbiology. Meet over 500 colleagues as part of the speaker team in Darmstadt. We also welcome poster requests.

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FDA Warning Letter: 1,500 OOS Results with Numerous Inadequate Investigations

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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EMA/CMDh: Nitrosamines Q&A Document updated again

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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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.

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