The ECA Foundation and the Pharmaceutical Quality Group (PQG) have been working on the interpretation of different chapters of the EU GDP Guideline. The interpretation of five chapters have been published already. The following 5 Guidance chapters on the EU GDP Guideline are available:
Chapter 1: Quality Management
Chapter 9: Transportation
Chapter 7: Outsourced Activities (also contains a template for a Technical Agreement)
Chapter 2: Personnel
Chapter 5: Operations
Now the group has finalized the work on chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products & Medicinal Product Recalls. Chapter 6 of the EU GDP Guideline requires that all complaints, returns, suspected falsified medicinal products and recalls must be recorded and handled carefully according to written procedures. Some returned medicinal products might be released for resale. The handling should be performed only after an assessment of the returned medicinal products. The approval should be made by the Responsible Person (RP). Also complaints must be handled based on a written procedure and all details of each complaint must be recorded. Finally, the identification and handling of Falisified Medicinal Products are also defined in chapter 6. The ECA/PQG Guidance document provides information on how to implement the requirements.
You will find chapter 6 and all other GDP Guidance chapters in the members area of the GDP Group Webpage. Membership is available at no costs.