ECA and PQG publish next chapter of the interpretation of the EU GDP Guide

The ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG) have published an additional chapter of the interpretation of the EU Good Distribution Practice (GDP Guide).

The Joint Task Force has already published the GDP interpretation of chapter 1 Quality Management, chapter 9 Transportation, Chapter 7 Outsourced Activities and chapter 2 Personnel.

Now the Working Group has released Chapter 5 Operations. The Chapter deals with a number of critical GDP activities like qualification of suppliers and customers, receipt and storage of medicinal products, picking, export to third countries and other elements. The Guidance document is structured in three parts for each GDP requirement. The original text is mentioned and the Guidance documents provides information on:

  • what is the rationale for the point in the Guidance
  • what are the risks and benefits associated with this aspect of the relevant aspect in the guidance
  • how might this requirement be implemented/what does this mean

By this the Guidance the joint Working Group provides answers to readers of the EU GDP Guideline. For example the issue of qualification of supplier raised a lot of questions by companies who are implementing the GDP requirements. The ECA/PQG Guide provides more information and can serve as a checklist to check for implementation.

The ECA/PQG Guidance on the interpretation and implementation of EU GDP Chapter 5 Operations is available at no costs.

Please find more information about the ECA Working Group on GDP. There you will also find the application form for a free membership.

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