ECA/PQG Working Group finalises GDP Interpretation Guide

Recommendation

28/29 October 2020

Live Online Training: The GDP Audit

The last three chapters of an interpretation of the EU Good Distribution Practice Guide (GDP) have been published jointly by the ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG). Both organisations joined forces to develop a Guide intended to help colleagues in industry with the implementation of the EU GDP Guideline.

The new publications focus on Chapter 3 Premises and Equipment, Chapter 4 Documentation and Chapter 10 Brokers. As with the other guidance documents of the working group, these elaborate the rationale for the various subchapters and give guidance for interpretation and implementation.

The guidance on the interpretation and implementation of Chapter 3 contains two appendices; a template for a temperature mapping protocol and a template for the respecive report.

The new chapters complement the already published chapters:

• Chapter 1: Quality Management
• Chapter 2: Personnel
• Chapter 5: Operations
• Chapter 6: Complaints, Returns, Suspected Falsified Medicinal Products & Medicinal Product Recalls
• Chapter 7: Outsourced Activities
• Chapter 8: Self Inspections
• Chapter 9: Transportation

All chapters as well as the new Code for Practice for Responsible Persons can be downloaded from the ECA GDP Group Webpage after registration.