News

Two new PICS Documents on Remote Assessments published

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two documents for inspectors related to remote assessments. Although the documents are primarily intended for GMP inspectors, they can also be useful for the GDP area (with appropriate modifications).

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The GDP Non-Compliance Reports of 2024 - An Overview

If the outcome of an inspection is that a wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into the EudraGMDP database. As in previous years, we have prepared an overview of the GDP Non-Compliance Reports issued in 2024, including the corresponding reasons for their issuance.

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IPEC: Updated GDP Guide for Excipients

In October 2024, the IPEC (International Pharmaceutical Excipients Council Europe (IPEC Europe) asbl) announced on its website the new version 3 of its GDP guide 'Good Distribution Practices Guide for Pharmaceutical Excipients'.

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GDP in the US: Pre-posting of USP Chapter <1079.2> on MKT

The United States Pharmacopeia (USP) has issued a pre-posting notice to inform of the anticipated publication of General Chapter <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products. This provides early access to the chapter due to strong regulatory interest in several Climatic Zone IVb countries.

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Romanian Authority Issues further GDP Non-Compliance Report

We recently reported on two GDP Non-Compliance Reports issued by the Romanian authorities. Now, an additional report concerning a Romanian wholesaler has been published in the EudraGMDP database.

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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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