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The FDA has issued a Warning Letter to a manufacturer in the USA who has not adequately tested its drug products. And the manufacturer relied on others for supplier qualification.

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In a Warning Letter, the FDA describes the inadequate cleaning of product-contact surfaces and the associated risk of cross-contamination at an Egyptian pharmaceutical manufacturer.

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The Mutual Recognition Agreement (MRA) between the EU and the US will be extended to veterinary medicines. This was announced by the EU Commission in a press release.

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The U.S. Food and Drug Administration (FDA) has published a Form 483. During an inspection at an Indian drug manufacturing side, several CGMP violations were documented. These concerns, among others, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, where results were invalidated by retesting the batches without a scientifically justified root cause.

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In March 2023, the ECA offered the Live Online Training "How to register APIs in Brazil". With regard to Brazil's Registration procedures for APIs, a set of the most important questions raised during the training and the respective answers provided by the speakers Ms Marieke van Dalen, Global Regulatory Specialist, Aspen, The Netherlands, and Ms Susan Swiggers, Customer & Regulatory Support Officer, Aspen, The Netherlands, are listed in the following.

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Good Manufacturing Practice is referred to as GMP in the EU, in almost all PIC/S countries and at WHO. The FDA, however, refers to it as CGMP. But what exactly is behind it? The FDA has published a paper on this.

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Due to deficiencies found in an FDA inspection, a US pharmaceutical manufacturer has now received a Warning Letter. Among other things, a dead leg in the pharmaceutical water system is listed as a deficiency.

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The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. An OTC manufacturer received information indicating that the finished drug products produced with isobutane propellants were contaminated with benzene. The company's own analyses as well as results of the FDA laboratory testing confirmed the presence of this impurity. The company failed to perform adequate investigations and so far, the root cause of the benzene contamination is not understood.

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In March 2023, the EDQM once more prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" and has now published it in the newsroom of the EDQM website.

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The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a OTC drug manufacturer in Mexico. No procedure to handle OOS results was in place, and drug product with OOS results were released and distributed. There was also a lack of stability data and the quality unit did not provide adequate oversight.

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