News

It is important to understand that (quality) risk management is essential to the implementation and maintenance of Data Integrity concepts. In order to control the risks they need to be categorized. Such a categorization must be simple and easy to be applied fast, consistently and reliably.

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Two new Non-Compliance Reports issued by the National Authority of Medicines and Medical Devices of Romania (NAMMDR) are currently available in the EudraGMDP database. Both concern wholesale distributors whose activities were fully suspended due to violations of GDP requirements.

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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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The U.S. FDA issued now a Warning Letter (WL) to a South Korean company after having inspected its site in November 2024. According to U.S. FDA Warning Letter, the firm failed to do "adequate investigations of recurring complaints" related to their finished products' packaging materials, even so these complaints occurred more than one time.

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The question we want to explore is whether Data Integrity is a completely new approach or just a different perspective on already existing GMP requirements as those arising from ICH Q7.

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In a news dated 24 September 2025, we referred to an FDA guideline on 'remote oversight tools'. The exact title is 'Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications'. It presents alternatives to on-site inspections in the context of applying for approval.

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In mid-September 2025, the updated so called Classification Guideline was published on the European Union (EU) website and will therefore be mandatory from mid-January 2026 (15 January 2026). It was revised and expanded as part of the update to the Variations Regulation.

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The FDA has published a final Guidance Document on the possible use of alternative methods in the preparation of inspections or even in place of inspections for pending marketing authorisation applications.

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Again, four Warning Letters from the FDA were published, criticising not only inadequate Quality Oversight but also the Root Cause Analysis and CAPAs implemented. One company in India and three in the USA were affected.

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In July and September 2025, the Questions & Answers documents relating to centralised authorisation procedures were updated again and published on the European Medicines Agency (EMA) website.

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