Analytical Quality Control News

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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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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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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FDA Warning Letter Highlights Deficiencies in SST and HPLC Practices

Robust system suitability, validated data handling processes and strict user-access controls are essential components of any GMP compliant HPLC or GC workflow. A recent FDA Warning Letter underscores how quickly inadequate system suitability testing (SST) and weak chromatographic controls can undermine data integrity and product quality.

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Proposed Revision of USP <1225> Published in the Pharmacopeial Forum

In the Pharmacopeial Forum, PF 51(6), a proposed revision of USP General Chapter <1225> has been published. The revision includes a title change from "Validation of Compendial Procedures" to "Validation of Analytical Procedures", reflecting the broader applicability of the chapter to both compendial and non-compendial analytical procedures.

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Recent Publications Highlighting Topics to be Discussed at PharmaLab 2025

In the run-up to PharmaLab 2025 in Neuss from 24 to 26 November, several articles have been published that provide insights into current developments and discussions in the field of analytical quality control.

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USP seeks early Input on new NMR Method

USP has announced a General Chapter Prospectus for a proposed new chapter <319> Nuclear Magnetic Resonance Spectroscopy Block Length Determination for Lactide-Glycolide Polymers. Stakeholders are invited to provide early feedback by 30 November 2025, ahead of an anticipated proposal in PF 52(2) (March–April 2026).

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