Good Distribution Practices News

16.09.15

IMPs: How do GDP Guidelines apply?

The 2013 Guidelines on Good Distribution Practice  apply to medicinal products for human use. Investigational Medicinal Products (IMPs) are also medicinal products for human use. But is IMP distribution really covered by the new Guidelines?

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09.09.15

GDP Non-Compliance Report for Czech Company D-Pharm

On 21st July 2015 the competent authority of the Czech Republic has issued a EU GDP Non-Compliance report to a wholesale distributor. Please read more about the GDP-Non Compliance Report.

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24.06.15

GDP Guidelines now also valid in Switzerland

From July 1, the EU guidelines on Good Distribution Practice of medicinal products for human use (GDP Guidelines) will apply also in Switzerland. This is done by an Adaptation of Annex 2 of the Medicinal Products Approval Regulation (Arzneimittel-Bewilligungsverordnung - AMBV).

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10.06.15

WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products

The WHO has published a set of technical guidance documents giving interesting and detailed information on temperature-controlled transport operations. Read more in the technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products.

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03.06.15

EU GMP: new Annex 21 on the Way

The GMP/GDP Inspectors Working Party is planning to implement a new Annex 21 to the EU GMP Guidelines focussing on the import of medicinal products.

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27.05.15

From an FDA Perspective: The US Drug Supply Chain and Patient Safety

Ilisa Bernstein, Deputy Director of FDA's Center for Drug Evaluation and Research's Office of Compliance, shares her thoughts on the important role drug supply chain integrity plays in patient safety and quality care.

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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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