ECA/PQG Working Group publishes Chapter 8 of the GDP Interpretation Guide

Recommendation

Tuesday, 26 October 2021 9 .00 - 17.00 h

Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals - Live Online

A new chapter of an interpretation of the EU Good Distribution Practice Guide (GDP) has 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 publication is an interpretation of chapter 8 "Self Inspections". It not only explains the requirements but also provides practical advice. For that reason it contains 3 Word documents which can be used for daily work:

• Self-Inspection Checklist for EU GDP Compliance  
• Examples of checks to be performed for selection of Transportation Company; possible checklist for Customer Qualification
• Template: Possible content of a Standard Operating Procedure (SOP) for Self-inspection: Performance, responsibility, reporting

The new chapter complements 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 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.