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Qualified Person Education Course Module B

4-6 June 2025
Vienna, Austria


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Document and track your personal development - with the Continuous Professional Development (CPD) Documentation Template

To access the template for documenting and tracking your past and ongoing activities, please go here.

After filling out the form, you will be able to create and print out a PDF file.

ECA/PQG Working Group finalises GDP Interpretation Guide

27/04/2016

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.


 

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