Good Distribution Practices News

The competent authority of Germany has entered a new GPD Non-Compliance Report dated 21 July 2021 into the EudraGMDP database due to critical violations of GDP requirements. One of the reasons is that the Responsible Person (RP) does not fulfil the responsibilities personally and is not continuously contactable.

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The European GDP Association has answered these questions and combined them in a Q&A document.

Last year, the Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance called "Acting as a Responsible Person (import) ". The guidance describes the role of the Responsible Person (import) (RPi) and how to become a RPi. This guidance was now updated, listing extensive qualification requirements for RPi's.

Parallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing-authorisation holder. In this context, the European Medicines Agency (EMA) has recently published a new comprehensive Q&A document containing answers to the most common questions.

The European Commission has published Version 18b of the "Questions & Answers" on safety features. In particular the update took into account the new ISO standard for Packaging Tamper verification features.

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 4 deals with questions related to documentation.

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 3 deals with questions related to the Quality Management System (QMS).