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Stimuli Article Proposes Revision of USP Definition of Controlled Room Temperature (CRT)

The United States Pharmacopeia (USP) is considering a revision to its definition of controlled room temperature (CRT), aligning it with the ranges recommended by the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and World Health Organization (WHO). A Stimuli article published in the current Pharmacopeial Forum, PF 51(3), highlights that the existing discrepancy between USP’s CRT definition (20°–25°C) and the JP, EP, and WHO standards (15°–25°C) leads to inconsistencies in drug storage practices and increased energy consumption.

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Survey on GDP Implementation

The European GDP Association (GDPA) is conducting a survey to gather insights into the implementation of GDP requirements across different regions. We invite all stakeholders involved in GDP to take part in this initiative. Participation will take only about 10 to 15 minutes.

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GDP Non-Compliance Report: No Responsible Person, proper Storage and Distribution not ensured

The Competent Authority of Germany (Landesamt Fuer Gesundheit Und Soziales Mecklenburg Vorpommern) has entered a new GDP Non-Compliance Report into the EudraGMDP database.

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New Version of the HPRA GDP Guide Published

In April 2025, the Health Products Regulatory Authority (HPRA) released Version 8 of its Guide to Good Distribution Practice of Medicinal Products for Human Use. While primarily aimed at wholesalers and brokers based in Ireland, the updated guide provides insights into regulatory expectations that are relevant for all stakeholders involved in the distribution of medicines across the EU.

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GDP in the US: Updates on Implementation of DSCSA

On 26 March 2025, the FDA and the Partnership for DSCSA Governance (PDG) held a virtual town hall focusing on the upcoming end of the manufacturer exemption under the Drug Supply Chain Security Act (DSCSA). Two further sessions are planned for wolesale distributors and dspensers.

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Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 2

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 2 here.

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Tasks and Duties of the Responsible Person according to the EU GDP Guidelines

Good Distribution Practice (GDP) places high demands on the Responsible Person. This role is crucial for complying with legal and regulatory requirements and for ensuring the quality and integrity of medicinal products throughout the distribution process. But what specific tasks and responsibilities does this position involve?

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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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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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