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As part of the implementation of the new "CEP 2.0", the EDQM has now published on its website a list of authorities and organizations that have insight into inspection and assessment reports.

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The Turkish Medicines and Medical Devices Agency (TITCK) has published a new revision of its guidelines related to inspections regarding the storage and distribution of medicinal products for human use.

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The FDA has updated one of its internal manuals to add a risk factor for facilities in countries where there has been an increase in violations. This is nothing more than a risk factor for a region or an entire country.

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Due to numerous GMP deficiencies, a US company in the field of solid dosage form packaging received a Warning Letter from the FDA. The inspection had already taken place in November 2022. Since the FDA found the company's response to the Form 483 as insufficient, the Warning Letter now followed.

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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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