News

Strategic Report published by the Critical Medicines Alliance

On 28 February 2025, the Critical Medicines Alliance issued its Strategic Report, which contains key industry challenges and recommendations to strengthen the security and robustness of the supply chains of critical medicines in the EU.

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Falsified Medicinal Products: Swissmedic Intensifies Controls on International Trade

Swissmedic – the Swiss authority responsible for the authorisation and supervision of therapeutic products – is responding to cases of falsified products with stricter controls. A recent targeted campaign has uncovered shortcomings in international trade with suppliers from non-EU countries.

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Two GDP Non-Compliance Reports published in March

Two new GDP Non-Compliance Reports were recently published in the EudraGMDP database – one concerning a wholesale distributor in Cyprus, the other involving a distributor based in Austria.

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Visit the DHL Vienna Airport Campus

The DHL Vienna Airport Campus is a strategically important logistics hub for Austria and Eastern Europe. As part of the ECA training "GDP for Beginners", participants benefit from an exclusive airport tour, organized in cooperation with DHL. This behind-the-scenes experience offers insights into logistics operations and infrastructure.

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EMA's 3-Year Work Plan for GMDP Inspectors Working Group: What's Planned for GDP?

The European Medicines Agency (EMA) has published the three-year work plan (2025–2027) of the GMDP Inspectors Working Group, along with the group’s annual report for 2024. In addition to addressing numerous GMP-related topics, both documents also highlight important aspects relevant to the GDP sector. A key focus of the work plan is on ensuring the integrity and resilience of the supply chain.

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MHRA Class 2 Recall due to Blister Pack Mislabeling

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall due to a critical labeling error in one batch of Paracetamol 500 mg tablets. The blister packs inside the affected cartons incorrectly state 'Aspirin 300 mg Dispersible Tablets' instead of 'Paracetamol 500 mg'. This incident reveals a failure in the Quality Management System (QMS) and a lapse in oversight by the Qualified Person (QP), while also highlighting the important role of wholesalers and pharmacies in promptly removing affected batches to prevent medication errors.

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Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 1

Around 60 participants attended the ECA Webinar "GDP Update 2025" in March. Many interesting aspects were discussed in the Q&A session. After the event, the speaker, Dr. Christian Grote-Westrick, answered the submitted questions in writing. We have compiled a selection of these questions and answers for you – read Part 1 here.

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USP Publishes Summary of Comments on Chapter <1079.2> Regarding Mean Kinetic Temperature (MKT)

The United States Pharmacopeia (USP) has provided responses to stakeholder feedback on the proposed revisions to General Chapter <1079.2>, Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products.

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EMA: No further Extension of GDP Certificates in 2025

The GMP/GDP Inspectors Working Group decided at the end of 2023 to extend the validity of GDP and GMP certificates that expired at the end of the year until 2024 or until the next on-site inspection, whichever occurs first. It has now been clarified that from 2025, this extension no longer applies.

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Aide-Mémoires and Checklists in GDP Audits - Benefits and Risks

Aide-mémoires and checklists support a structured approach in GDP audits, ensuring that all relevant aspects are considered. In this article, we examine how these tools can be used effectively, the risks they may entail, and what auditors should pay special attention to.

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