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Swissmedic publishes Technical Interpretation on Shipment under Quarantine

Swissmedic, the Swiss national authorisation and supervisory authority for drugs and medical products, has published a new document on "Shipment under Quarantine". It clarifies some situations in which a shipment under quarantine of active substances, intermediate drug products and finished drug products would be acceptable to inspectors.

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Checklist for Implementation of GDP Principles - Part 5: Operations

According to Chapter 5 of the EU GDP Guidelines, all actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain. In this article, you will find a checklist to verify the minimum implementation.

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Abbreviations in the GDP Environment - Extended List

During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. The overview first published a few months ago has now been extended.

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Checklist for Implementation of GDP Principles - Part 4: Documentation

Chapter 4 of the EU GDP Guidelines points out that good documentation constitutes are an essential part of the quality system. In this article, you will find a checklist to verify the minimum implementation.

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New Entries in the ECA Discussion Forum

The European GDP Association offers a Discussion Forum free of charge for its members. It gives you the opportunity to address your GDP-related questions to a large audience. Several interesting topics have been discussed over the last few weeks. To get an idea, take a look here.

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GDP Non-Compliance Report for Austrian API Distributor

The Austrian Agency for Health and Food Safety has entered a new GDP Non-Compliance Report into the EudraGMDP database. This affects an active substance (API) distributor.

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Falsified Medicines in the Legal Supply Chain

Falsified medicines do not meet the standards of safety, efficacy and quality as are required and may pose a serious risk to public and animal health. That is why the topic is explicitly addressed in the EU GDP guidelines. Despite all precautions, several examples have recently come to light in which counterfeit medicines have entered the legal supply chain. 

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The GDP Non-Compliance Reports of 2023 - An Overview

If the outcome of an inspection is that the wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into EudraGMDP. As in previous years, we have prepared an overview of the GDP Non-Compliance Reports published in 2023 and the respective reasons for issuing these reports.

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Checklist for Implementation of GDP Principles - Part 3: Premises and Equipment

According to Chapter 3 of the EU GDP Guidelines, wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products. In this article, you will find a checklist to verify the minimum implementation.

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Ozempic Falsification also in the US

Following the previously confirmed falsifications of Ozempic® batches in the EU drug supply chain, the FDA now warned consumers not to use counterfeit Ozempic® found in the US drug supply chain.

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