Analytical Quality Control News

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 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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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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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: 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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