Good Distribution Practices News

17.03.22

How often should GDP Self-Inspections be performed?

According to the GDP guidelines, regular self-inspections should be performed. But what is considered as an appropriate regular interval?

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17.03.22

U.S. Pharmaceutical Distribution Supply Chain: Revised Draft Guidance on Verification Systems

The U.S. Food and Drug Administration (FDA) has issued a revised draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs. This document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place.

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15.02.22

Proposed Rule for the Licensure of WDDs and 3PLs published

The U.S. Food and Drug Administration (FDA) has announced the availability of the proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs). According to the agency, the proposed rule, when finalized, would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain.

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15.02.22

GDP Non-Compliance Report due to GDP Violations concerning RP, Supplier Qualification, Operations and Trading

The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 18 January 2022 into the EudraGMDP database.

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15.02.22

The GDP Discussion Forum

The European GDP Association, representing more than 4.000 professionals from across the globe, offers a Discussion Forum free of charge for its members. It gives you the opportunity to address your GDP-related questions to a large audience. To get an idea, take a look here.

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15.02.22

Active and Passive Shipping Systems and Transport Equipment

In this article, we will provide some information and examples of active and passive shipping systems and equipment used for the transport of time and temperature sensitive pharma products.

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09.02.22

EU: Strengthening the EMA

A regulation strengthening the role of the EMA in crisis preparedness and management has been published in the Official Journal of the EU. The document also assigns several new tasks to the EMA.

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18.01.22

EU Commission amends Delegated Regulation on Safety Features again

In order to ensure that medicinal products continue to be marketed with a unique identifier (UI) in Northern Ireland, Cyprus, Ireland and Malta, the Commission further extends the temporary derogation from the requirement to decommission UIs of products exported to UK.

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18.01.22

Wholesale Distribution of Medicinal Products - Obligation to Notify Changes

Wholesale trading of medicinal products in Germany requires an authorisation according to Section 52a of the Medicinal Products Act (Arzneimittelgesetz – AMG). The holder of the authorisation must notify the competent authority in advance of any fundamental changes. A wholesaler from Brandenburg, Germany, did not comply with this notification requirement, as a GDP Non-Compliance Report published in October 2021 shows.

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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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