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In December, the FDA published a Warning Letter to a manufacturer of OTC products, in which it identified deficiencies in both the handling of microbiological deviations and the validation of alternative rapid microbiological methods. The testing and analysis of raw materials used for contamination was also inadequate.

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In December 2025, the IPEC announced the new version 1 of its 'Best Practices Guide for European REACH Restriction on Synthetic Polymer Microparticles (SPM) for Pharmaceutical Excipients (Version 1, 2025)' in a notice on its website.

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In January 2026, the U.S. FDA issued a Warning Letter to the Indian company "Chemspec Chemicals Private Limited" after having inspected its site in July/August 2025. The observation mentioned in the Warning Letter is related to the lack of Quality Oversight, Good Documentation Practices and Data Integrity principles.

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An FDA inspection identified systemic deficiencies in a company's Quality Unit oversight, including inadequate supplier qualification. The case underscores the expectations that supplier qualification and oversight must be fully integrated and actively overseen by the Quality Unit.

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The FDA inspected a US manufacturer of OTC products and found the water system to be deficient. Along with other observations, this has now led to a Warning Letter.

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Find out what the GMP Auditor Association was working on and accomplished in the last four months of 2025 - in the latest report.

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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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