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Recall of Product Samples from U.S. Market Due to Improper Storage Temperature Conditions

A global healthcare company is voluntarily recalling 1,468 product samples from the U.S. market because they were stored at temperatures below storage requirements. The products affected are used to lower blood glucose levels in people with diabetes. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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FIFO, FEFO, LIFO: What is the meaning?

FIFO, FEFO and LIFO are the three main strategies for warehouse management. But what do the three abbreviations actually stand for and what exactly do they mean?

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Questions & Answers on Good Distribution Practices (GDP) - Part 4

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 4 deals with questions related to documentation.

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GDP Non-Compliance Report for Romanian Wholesale Distributor

The competent authority of Romania (National Agency for Medicines and Medical Devices of Romania) has entered a new GPD Non-Compliance Report dated 15 April 2021 into the EudraGMDP database.

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GDP-Non-Compliance-Report for German Wholesale Distributor

The Competent Authority of Germany (Bezirksregierung Düsseldorf) has entered a new GPD Non-Compliance Report dated into the EudraGMDP database due to serious GDP violations at a German wholesaler. The case involves trading of falsified medicinal products and storage of expired medicinal products in regular stock. Furthermore, there are doubts on the reliability of the Reponsible Person and the CEO due to an ongoing criminal procedure.

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Questions & Answers on Good Distribution Practices (GDP) - Part 3

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 3 deals with questions related to the Quality Management System (QMS).

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Track & Trace: Amendment of the Delegated Regulation on Safety Features

On 17 March 2021, the Delegated Regulation (EU) 2021/457 was published in the Official Journal of the European Union. It amends the Delegated Regulation 2016/161 regarding an exemption from the obligation for wholesalers to decommission the unique identifier (UI) of medicinal products exported to the UK.

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Supplier Qualification for Packaging Material

USP´s Packaging and Distribution Joint Subcommittee posted a proposal for the development of a new General Chapter <1xxx> Supplier Qualifications.

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Is Medical Cannabis a Medicinal Product?

The Higher Regional Court (OLG) of Hamburg has decided, in the context of proceedings aimed at the issuance of an interim injunction against a wholesaler, that medical cannabis (cannabis flowers) is not (yet) a medicinal product at the wholesale level.

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Judgement of Federal Administrative Court of Germany on the Required Expertise of the Responsible Person for GDP

The Federal Administrative Court of Germany (Bundesverwaltungsgericht - BVerwG) has dealt with the question of what requirements are to be placed on the expertise of the Responsible Person for GDP. In a recently published judgment, the court has clarified that knowledge of pharmacy comparable to that taught in a pharmaceutical (vocational) training is not required. Rather, the knowledge can also be gained through practical experience.

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