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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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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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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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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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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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