News

New USP Chapter <1079.5> Transportation Lane Temperature Mapping and Qualification Published for Comments

In the Pharmacopeial Forum, PF 51(5), a proposal for a new USP General Chapter <1079.5> Transportation Lane Temperature Mapping and Qualification, as well as an accompanying Stimuli article entitled "Transportation Lane Temperature Mapping and Qualification—Risk Identification and Evaluation," were published.

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Results of the GDP Survey: Detailed Report Available for Download

As previously reported, the European GDP Association (GDPA) conducted a survey on the practical implementation of GDP requirements in the pharmaceutical supply chain. The full report with all results is now available for free download in the GDPA members’ area.

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BioPhorum Survey on -40 °C Drug Substance Storage Practices

A new BioPhorum publication summarizes the results of a 2025 cross-industry survey on -40 °C storage practices for biologic drug substance and provides insights into current industry approaches, risks, and best practices.

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GDP Non-Compliance Report: No Responsible Pharmacist

The Competent Authority of France (ANSM) has posted a new Statement of Non-Compliance with GDP in the EudraGMDP database. According to the report, the company's responsible pharmacist and deputy ceased their activities. However, the company did not appoint replacements or notify ANSM of such appointments.

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European GDP Association Developments May through August 2025

Find out what the European GDP Association was working on and accomplished from May to August 2025 - in the latest report.

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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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