Good Distribution Practices News

18.01.22

The GDP Non-Compliance Reports of 2021 - An Overview

Wholesale trade in medicinal products requires a wholesale authorisation. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority. If the outcome of an inspection is that the wholesale Distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP. For your information please see the comprehensive overview of the GDP non-compliance reports entered in 2021 and the respective reasons for issuing them.

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21.12.21

Change in the Board of the European GDP Association

The European GDP Association has recently announced a change in the Board. Emil Schwan moves from the Board to the Authority Advisory Board.

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21.12.21

Revised IPEC GDP Audit Guide for Pharmaceutical Excipients Available to the General Public

In September 2021, the International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients (Version 3, 2021). After the guide was initially only accessible exclusively to IPEC members for three months, the document was now made available to the general public.

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21.12.21

GDP Non-Compliance Report for German Wholesale Distributor: No GDP Conform Quality System and No Suitable and Adequate Premises

The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 03 December 2021 into the EudraGMDP database. Due to the seriousness of the violations, the Wholesale Distributor Authorisation was revoked.

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21.12.21

GDP for Veterinary Medicinal Products: Implementing Regulation (EU) 2021/1248 of 29 July 2021

In August 2021, the new Commission Implementing Regulation (EU) 2021/1248 on measures on good distribution practice for veterinary medicinal products entered into force. Read more in the summary of the most important aspects of the new document.

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08.12.21

Q&As from the EMA Webinar for Industry on Integration of EudraGMDP and OMS

At the beginning of October, we reported on important changes for entries in the EudraGMDP Database. To inform about the new developments, the EMA had organized a webinar for industry on the integration of EudraGMDP and OMS. The EMA has now published a 13-page Q&A document with 87 questions raised during that webinar.

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23.11.21

GDP for APIs used as Starting Materials in Veterinary Medicinal Products: Implementing Regulation (EU) 2021/1280 of 2 August 2021

The Commission Implementing Regulation (EU) 2021/1280 lays down the good distribution practices for active substances used as starting materials in veterinary medicinal products. It applies to importers, distributors, and manufacturers. The Regulation has been binding since August 2021 and is directly applicable in all Member States. We have summarised the most important requirements of the new Regulation.

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23.11.21

GDP Certificates and Wholesale Authorisations Automatically Extended until the End of 2022

In light of ongoing difficulties to conduct on-site GDP inspections due to restrictions arising from the COVID-19 pandemic, GDP certificates and time-limited wholesale authorisations for sites in the European Economic Area (EEA) are automatically extended until the end of 2022.

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23.11.21

Documents Accessible Free of Charge in the Member's Area of the European GDP Association

Do you know that many supporting documents are available free of charge in the member's area of the European GDP Association? To get an idea, take a look here.

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28.10.21

Recording of MHRA Supply Chain Webinar Available

On 13 August 2021, the Medicines & Healthcare products Regulatory Agency (MHRA) held a webinar "Protecting the medicines supply chain from falsified medicines". A link to the recording and updated information addressing some key questions received during this webinar have now been published on the MHRA Inspectorate blog.

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28.10.21

Written GDP Training Programme: What does this mean in Practice?

Chapter 2 of the EU GDP Guidelines requires a written training programme. But what exactly does this mean and how can it be put into practice?

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28.10.21

Is it allowed to take personal medication into the storage area?

During several ECA events, the question came up whether it is allowed to take personal medication into the storage area.

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29.09.21

Serialization: Aide-Memoire for Pharmacies

The previously published Aide-Memoires for GDP and GMP Inspections regarding safety features are now accompanied by a third one: Aide-Memoire for Pharmacy Inspections. What are the obligations of persons authorized or entitled to supply medicinal products to the public?

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29.09.21

MHRA Guidance for the Supply of Medical Cannabis Products

The MHRA published an updated Guidance on manufacturing, importing, distributing and supplying of cannabis-based products for medicinal use. Amongst others, the MHRA will require a valid GMP certificate for the site of manufacture.

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28.09.21

Record Number of Fake Drugs seized during INTERPOL Operation

During an action week coordinated by INTERPOL against illegal internet trade checks led to the discovery of very large numbers of fake and illicit drugs. Overall the operation resulted in the seizure of around 9 million medical devices and illicit pharmaceuticals.

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