Thursday, 20 April 2023 10.00 - 16.30 h
The Pharmaceutical Quality Group (PQG) and the GDP Interest Group of the ECA Foundation have established a task force which is currently working on the interpretation of the EU Good Distribution Practice (GDP) Guide. Indeed, since the publication of the revised version of the EU GDP Guide by the EU Commission, many questions about interpretation and implementation have been raised.
The task force has already provided an interpretation on 3 chapters of the EU GDP Guide. The first was the interpretation of the GDP chapters 1 (Quality Management) and 9 transportation. Later, the group developed an interpretation on chapter 7 of the EU GDP Guide which deals with outsourced activities. On September 1st, the group finalized the GDP interpretation on chapter 2 Personnel. This chapter has raised a lot of discussions in the industry - especially about the role of the Responsible Person for GDP.
The document developed by the PQG together with the ECA Foundation is available here: Guidance on the interpretation and implementation of European Good Distribution Practice Chapter 2 – Personnel.