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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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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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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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In a recently issued Warning Letter, the U.S. Food and Drug Administration (FDA) highlights substantial deficiencies in analytical release testing, method validation, stability testing, and data integrity at a drug manufacturing site in China. Several observations are repeat findings, indicating ongoing gaps in quality oversight and management control.

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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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Update EU/US MRA: EU can now also rely on FDA third-country inspections. This can be found in the updated Q&A document.

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The FDA is currently citing significant deficiencies in root cause analysis, CAPA implementation and monitoring by the quality assurance unit (QU) with increasing frequency. This is also the case in a recent Warning Letter to a company in the USA.

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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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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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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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