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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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In November and December 2025, the ‘Questions & Answers (Q&A)’ document ‘European Medicines Agency post-authorisation procedural advice for users of the centralised procedure’, which addresses topics that may be relevant after marketing authorisations has been granted, was updated and published on the website of the European Medicines Agency (EMA).

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In October 2025, the 'Questions & Answers (Q&A)' document relating to topics before and during the application process - 'European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure' - was updated again and published on the website of the European Medicines Agency (EMA).

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Conducting GMP audits is an essential tool for monitoring and continuously improving pharmaceutical quality systems. But what are the requirements?

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During an inspection in spring 2025, the FDA identified serious violations of GMP requirements at a US manufacturing facility for topical OTC medicines. The FDA deemed the response letter submitted to be insufficient, as it did not provide any reliable evidence or specific corrective measures.

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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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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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Robust system suitability, validated data handling processes and strict user-access controls are essential components of any GMP compliant HPLC or GC workflow. A recent FDA Warning Letter underscores how quickly inadequate system suitability testing (SST) and weak chromatographic controls can undermine data integrity and product quality.

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Almost every week, the US FDA publishes Warning Letters criticising companies for their Root Cause Analysis (RCA) and CAPAs. Two recent Warning Letters highlight recurring deficiencies in Root Cause Analysis and CAPA execution.

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At the beginning of November, the document “Stepwise process to get a CEP/having a change approved” was published on the EDQM website for the first time. This document is intended as a guidance document and clearly outlines the steps and processes required to obtain a CEP. It furthermore sets out timelines for new submissions and changes.

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