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Swissmedic updates Guideline for Conducting Inspections

Swissmedic has updated the Directive "Conduct of inspections of establishments manufacturing or distributing medicinal products or collecting blood". Version 4.0 was approved on 21 October 2024.

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BioPhorum Article on Resilience of the Supply Chain

BioPhorum recently published a new document entitled "Restarting the inbound supply chain: a BioPhorum Supply Partnering and Relationship Management position paper". 

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Romanian Authority Issues two new GDP Non-Compliance Reports

The Competent Authority of Romania (National Authority Of Medicines And Medical Devices) has issued two new GDP Non-Compliance Reports related to human medicinal products in the EudraGMDP database.

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New MHRA Guidance for Wholesalers and Manufacturers

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published a new "Wholesalers & manufacturers guidance following agreement of the Windsor Framework". The text contains guidance for wholesalers, Responsible Persons (RPs) and Responsible Persons for Import (RPis) in order to implement the arrangements of the Windsor Framework for human medicines.

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SwissGMDP Database now available

Swissmedic has made the new SwissGMDP database publicly available. The database lists all establishment licence holders domiciled in Switzerland, as well as all the operating sites and activities that are authorised. It is also possible to consult the GMP and GDP certificates.

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Abbreviations used in the GDP Environment

During several GDP events organized by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. The overview, initially published a few months ago, has now been further expanded.

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Swissmedic updates Responsible Person Requirements

Swissmedic has published an updated version of the Technical Interpretation "Responsible Person: Requirements (I-SMI.TI.17e)", which includes numerous clarifications. Although compliance with the previous version typically remains sufficient, some situations may require immediate action from license holders. The new interpretation is effective immediately.

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PDA publishes Technical Report on Last Mile Distribution

The Parenteral Drug Association (PDA) has published a new document - Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users. It provides details on temperature control, monitoring and security, and data management, with a focus on supply chain management. Furthermore, the document covers supply chains in Europe, Africa, Brazil, U.S., Canada and China.

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German Authority issues new GDP Non-Compliance Report

The competent authority of Germany (Bezirksregierung Koeln) has issued a new GDP Non-Compliance Report in the EudraGMDP database. During a reinspection, it was found that the issues from the inspection in October 2023 had not been resolved. Furthermore, new critical and serious findings were identified.

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Checklist for Implementation of GDP Principles - Part 10: Specific Provisions for Brokers

Chapter 10 of the EU GDP Guidelines describes the requirements for brokers. In this article, you will find a checklist to verify the minimum implementation.

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