Good Distribution Practices News

08.05.19

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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03.04.19

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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21.03.19

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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21.03.19

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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21.03.19

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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14.02.19

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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14.02.19

Hard Brexit: UK amends GDP Regulations

To face a possible Hard Brexit, UK plans to amend EU GDP Guidance.

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14.02.19

Blockchain - what is it about?

Blockchain should be able to help solve the challenges of the increasingly complex sales system. But what is Blockchain anyway?

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14.02.19

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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30.01.19

Hard Brexit: UK amends GMP and GDP Regulations

To face a possible Hard Brexit, UK plans to amend EU GMP Guidance.

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11.12.18

GDP Association updates Code of Practice for the Responsible Person for GDP

The Code of Practice "The Responsible Person for GDP" has been revised. The new Version 2 has just beed issued for members of the European GDP Association.

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11.12.18

Poor GMP/GDP Practice found in US Warehouse

In a warehouse in Arkansas, USA, the US Food and Drug Administration (FDA) found "alarming" insanitary conditions.

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31.10.18

Supply Chain and Drug Shortages Problems

What are the supply chain and drug shortage problems often caused by GMP and quality related problems? To find out more about this issue and about the consequences of drug shortages on the key stakeholders - i.e. the patients, companies and the governments -  the ECA conducted a survey. It also addressed potential strategies industry and authorities can employ to minimise the risk of drug shortage or its impact. Find out what the ECA survey on drug shortage problems brought to light.

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26.09.18

Version 10 of EU Q&As on Safety Features: Specific Questions on Bundle Packaging

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. The specific question of bundle packaging has also been addressed. Get more information about bundle packaging in EU's Q&A document on the safety features.

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26.09.18

"Ambient", "Room Temperature", "Cold " - what is what?

What are the regulatory requirements behind "ambient", "room temperature" and "cold chain"? The answer to the meaning of different storage conditions is not that easy.

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