ECA and PQG publish an additional chapter on the interpretation of the EU GDP Guide

Recommendation

7 September 2022
Bern, Switzerland

GDP in Switzerland (GDP 3)
Specifics in the Distribution of Medicinal Products (Course in english language!)

The European Compliance Academy (ECA) and the Pharmaceutical Quality Group (PQG) have announced the availability of chapter 7 "Outsourcing" on the interpretation of the new EU GDP Guideline.  The two organisations already prepared two draft chapters in October 2013. The first two chapters contained GDP interpretation of chapter 1 "Quality Management" and chapter 9 "Transportation".

The task force is led by Afshin Hosseiny (ECA Board Member) as well as by Philip Butson and Ashley McCraight. It is the aim of the workgroup to develop an interpretation of the EU Guide on Good Distribution Practices which was published in a revised version in 2013. In order to support stakeholders involved in the supply chain of medicinal products, the interpretation of the EU GDP Guide will be extended to all chapters.

The new released chapter "Outsourcing" not only contains the interpretation of the GDP Guide requirements but also a quality agreement template which can be used to develop a contract for outsourced GDP services.

Please download the new ECA/PQG draft chapter 7 "Outsourcing" here

Do not hesitate to send any feedback and suggestions for improvement to the email addresses: monographs@pqg.org or info@gmp-compliance.org.

The ECA offers the possibility to become member of the GDP Group: http://www.good-distribution-practice-group.org