Good Distribution Practices News

13.05.15

ECA and PQG publish Chapter 6 of the interpretation of the EU GDP Guideline

The ECA Foundation and the Pharmaceutical Quality Group (PQG) have been working on the interpretation of different chapters of the EU GDP Guideline. Now the group has finalized the work on chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products & Medicinal Product Recalls. Read more about the GDP Guidance Chapter 6.

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22.04.15

GDP: Is Temperature Control required for each Transport?

In the course of implementing the GDP Guidelines special questions concerning temperature control are recurring. There exists an interesting questions and answers document of the German authorities on this issue.

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08.04.15

Guideline to Register as a Broker of Medicinal Products

All Stakeholders dealing with Medicinal Products need to be registered and have to comply with GDP requirements. The MHRA has established a formalized procedure and also lists the brokers on their webpage. Read more about the Guideline for Brokers of Medicinal Products

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26.03.15

Good Distribution Practice (GDP) Training: How much is needed?

Since the EU Good Distribution Practice (GDP) Guide has been revised in March 2013 (an additional minor revision took place in November 2013) there is a lot of discussion about the interpretation of certain requirements. Among others, the training of personnel is a topic which received attention. Read more about the GDP requirements for training.

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26.03.15

GDP Certificates and WDAs in the EU Database - Improvement Needed

As one of the consequences from the Counterfeit Directive a European wide authorisation and monitoring system has been established. Each Wholesaler will need a Wholesale Distributor Authorisation (WDA). Those facilities that have been audited will receive a GDP certificate. Please read more about the WDAs and GDP certificates in EudraGMDP.

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15.01.15

EMA publishes new GDP non-compliance report for wholesaler in Norway

In addition to GMP also GDP non-compliance reports are entered into the European Database EudraGMDP.  The Norwegian Authority has issued a statement of non-compliance with GDP. Read more here.

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15.01.15

GDP Implementation: Harmonisation needed?

Our article deals with the implementation of the EU requirements into national law of the EU Member States and uses Germany as an example. In Germany, GDP implementation is laid down in the Trade Regulation for medicinal products. Nevertheless, the regulation contains some ambiguous formulations which lead to problems for implementing GDP. Read more about the implementation of GDP in Europe.

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15.01.15

Download 5 Chapters of the ECA/PQG Guide on Good Distribution Practice

The ECA Good Distribution Practices Group and the Pharmaceutical Quality Control Group have initiated a Working Group to develop an interpretation of the EU GDP Guideline. In order to better access the documents a new menu button has been added to the Members Area. Please read more here.

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12.11.14

Frequently asked Questions about Good Distribution Practice Implementation (EU)

The implementation of the new EU Good Distribution Practice Guideline is a challenging task for pharmaceutical companies, wholesalers, storage facilities and transportation companies. However, a very helpful document is available from the EU Commission which provides answers to a number of questions for GDP implementation. Read more about the Good Distribution Practice Q&As here.

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05.11.14

ECA and PQG publish next chapter of the interpretation of the EU GDP Guide

The ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG) have published an additional chapter of the interpretation of the EU Good Distribution Practice (GDP Guide). Click here to read more about the GDP interpretation

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29.10.14

New USP Chapters on Storage and Distribution under Way - but what is the Relevance?

The USP has announced that the deadline for comments on the new General Chapters on Storage and Distribution would be extended. Detailed information can be found in this News.

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23.09.14

If a Facility stores Medicinal Products for more than 36 Hours GDP will apply

Since the EU Good Distribution Practice (GDP) Guide has been revised, a number of questions regarding its interpretation have been raised. One of these questions relates to storage facilities and so called distribution hubs. The MHRA has provided guidance on this question. Please read more about the MHRA's interpretation of GDP.

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03.09.14

ECA and PQG publish next chapter of the GDP Interpretation Guide

The Pharmaceutical Quality Group (PQG) and the GDP Interest Group of the ECA Foundation have established a task force which is currently working on the interpretation of the EU Good Distribution Practice (GDP) Guide. Read more about the new GDP interpretation.

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06.08.14

PIC/S adopts EU GDP Guidelines

The Pharmaceutical Inspection Co-operation Scheme PIC/S has published a PIC/S Guide to GDP. This Guide is based on the EU GDP-Guidelines (2013/C 343/01) and quotes the EU Guide almost completely. Read more.

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30.07.14

IMPs: How do GDP Guidelines apply?

Is distribution of Investigational Medicinal Products covered by the new Guidelines on Good Distribution Practice (GDP)? What needs to be considered can be found here.

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