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Fiscal Importation within the EEA - Discussion of ECA GDP Survey Results

During the recent ECA GDP survey the implementation of GDP across members' countries, a number of interesting findings arose. Some of these will be discussed in upcoming issues of the ECA GDP Newsletter. The first topic in this series focuses on the current status of fiscal importation requirements within the EEA.

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MHRA Blog Post: GDP in the Aviation and Marine Sectors

The MHRA Inspectorate has informed readers that the blog post "A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors" is available on the MHRA website.

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Two new GDP Non-Compliance Reports from Romania

Two new Non-Compliance Reports issued by the National Authority of Medicines and Medical Devices of Romania (NAMMDR) are currently available in the EudraGMDP database. Both concern wholesale distributors whose activities were fully suspended due to violations of GDP requirements.

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Commercial GDP Certificates: Helpful Tool or Questionable Assurance?

Within the pharmaceutical supply chain, transport and logistics services are frequently outsourced to providers who, although not under direct regulatory oversight, must still comply with the EU GDP Guidelines. Commercial GDP certificates are one way of demonstrating such compliance. This article explores the role of commercial GDP certificates in pharmaceutical logistics.

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Mean Kinetic Temperature (MKT): Calculation, Benefits, and Limitations

The mean kinetic temperature (MKT) is a calculated value that describes the cumulative thermal load of a medicinal product over a certain period of time. In the context of storage and transport, it can be used to assess temperature deviations – however, its use is not always appropriate or permitted by regulations.

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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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