Analytical Quality Control News

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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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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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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FDA Warning Letter: Missing Tests, Missing Proof

In a recent Warning Letter, the U.S. Food and Drug Administration (FDA) highlights several GMP violations resulting from inadequate analytical testing, missing stability and validation data, and incomplete batch documentation.

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FDA Warning Letter: Missing Stability Testings

In October 2025, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dixon Investments Inc. dba ARI" after having inspected its site in March 2025. According to U.S. FDA Warning Letter, the firm failed to follow their stability procedures and test an adequate amount of their finished dosage forms.

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MAT Survey by the British NC3Rs

The British National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), with the support of other European authorities, the FDA and industry representatives, has published a survey on MAT in pyrogen testing and is calling for participation.

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FDA Warning Letter: From Inadequate Investigations and Laboratory Controls to Supplier Qualification and Process Validation.

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to a drug manufacturing facility in California. Inspectors identified inadequate investigations and CAPA management, missing identity testing for high-risk raw materials, and unvalidated manufacturing processes. The FDA also noted serious deficiencies in laboratory controls and overall quality oversight.

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Shelf Life vs. Retest Date - What's the Difference?

Both shelf life and the retest date are based on stability data, but they have different applications and implications, especially for the drug substance versus the drug product. So what exactly is the difference, and which regulatory requirements are most relevant?

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Mean Kinetic Temperature (MKT): Calculation, Benefits, and Limitations

The mean kinetic temperature (MKT) is a calculated value that describes the cumulative thermal load of a medicinal product over a certain period of time. In the context of storage and transport, it can be used to assess temperature deviations – however, its use is not always appropriate or permitted by regulations.

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FDA Warning Letter Highlights OOS Handling and Stability Failures

In late September 2025, the FDA published a new Warning Letter describing significant deficiencies at an OTC drug manufacturer. Inspectors identified critical issues related to data integrity, OOS investigations, stability testing, process validation, and quality oversight.

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