News

New WHO Draft for GDP Guidance

The World Health Organisation WHO plans to revise its Good Storage and Distribution Practice guidelines and to consolidate the rules in one single document.

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GDP-Inspector: Why Supplier Qualification is important

The MHRA explains in a Blog what supplier qualification means and why it is necessary to do it comprehensively.

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New office-based GDP-Inspection Process in UK

The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based GDP-Inspection process - without a visit of the site. 

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Q&As on Safety Features - Version 14

The European Commission published version 14 of the Q&A´s on Safety features for medicinal products for human use.

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Drug Shortages due to Brexit: EU gives Answers

The EMA has published a question-and-answer document on possible supply bottlenecks after Brexit.

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Brexit: GDP Updates for Import Activities and Air Freight

MHRA has published new Guidance for import and air freight activities. One is introducing a new function, the Responsible Person (import) - RPi.

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Hard Brexit: Liability Risk for Carriers

In the case of a "Hard Brexit", delays in import and export are to be expected. This will affect contracts and liability.

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Delivery of not ordered goods - what to do?

A wholesaler receives a delivery of a medicinal product. However, the order was not placed. What should be done?

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Current Activities of the GDP Association

The European GDP Association is quite active in supporting its members. What has been achieved in the past six months?

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FDA: New Steps to improve Supply Chain Security

The US Food and Drug Administration (FDA) is launching a new pilot project for enhanced tracing and verification approaches in the pharmaceutical distribution supply chain.

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