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Storing Medicinal Products Outdoors? Not a good Idea!

During storage, medicinal products should be protected from the negative effects of light, temperature, humidity, and other external factors. Outdoor storage typically does not meet these requirements and may lead to regulatory consequences – as demonstrated by a recently published FDA Warning Letter. In the case in question, the issue involved bulk totes of ethanol hand sanitizer intended for repackaging into smaller units.

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GDP Implementation Survey: Brief Summary

As previously reported, the European GDP Association (GDPA) conducted a survey on the practical implementation of GDP requirements in the pharmaceutical supply chain. Participation was open until 31 July 2025. A detailed report is currently being prepared – a brief summary of selected results is already available here.

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New Swissmedic Technical Interpretation on Returns of Medicinal Products

Swissmedic has published a new Technical Interpretation (TI) entitled "Requirements for the return of medicinal products" (I-SMI.TI.28e). The document defines the minimum requirements for wholesalers handling medicinal products returned by retailers, particularly with regard to the time limits that must be observed between delivery and return of the medicinal products.

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Two new GDP Non-Compliance Reports from Austria and Ireland published in the EudraGMDP database

Two new GDP Non-Compliance Reports from Austria and Ireland have been published in the EudraGMDP database. Both authorities document violations of the EU GDP guidelines and have revoked the Wholesale Distribution Authorisation (WDA) of the respective companies.

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Reminder: Participate in the GDP Implementation Survey until 31 July 2025

As previously reported, the European GDP Association (GDPA) is currently conducting a survey on the topic of GDP. If you have not yet participated, you can still complete the online questionnaire until 31 July.

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PDA Publishes Results of Transportation Validation Benchmarking Survey

The Parenteral Drug Association (PDA) has published the results of its 2025 Transportation Validation Benchmarking Survey. The survey aimed to gather industry benchmarking data on transportation qualification strategies within the pharmaceutical and biopharmaceutical industry.

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European GDP Association Developments January through April 2025

Find out what the European GDP Association was working on and accomplished in the first four months of 2025 - in the latest report.

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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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Meet the GDPA Board Members at the GDP Forum in Barcelona

The upcoming GDP Forum will be held on 25 and 26 June 2025 in Barcelona, Spain. Several Board Members of the European GDP Association are part of the speakers team. Find out here which topics will be covered at the GDP Forum.

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New MHRA Blog Post: Supplying Medicines to Ships, Aircraft and Oil Platforms

A new article titled “A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors” has been published on the MHRA Inspectorate blog. In this post, the Medicines and Healthcare products Regulatory Agency (MHRA) outlines key regulatory expectations, licensing requirements, delivery procedures, and specific considerations for recalls and repackaging when supplying medicines to the aviation and marine sectors – two environments that present unique logistical and compliance challenges.

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