Download 5 Chapters of the ECA/PQG Guide on Good Distribution Practice

Recommendation

13/14 December 2023

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The EU GDP Guideline defines a number of new requirements. However, the implementation into practice can cause a number of questions. This is why the ECA Good Distribution Practices Group and the Pharmaceutical Quality Control Group have initiated a Working Group to develop an interpretation of the EU GDP Guideline. Currently the following Chapters are available:

Chapter 1: Quality Management
Guidance on the interpretation and implementation of European Good Distribution Practice Chapter 1 – Quality Management

Chapter 9: Transportation
Guidance on the interpretation and implementation of European Good Distribution Practice Chapter 9 – Transportation

Chapter 7: Outsourced Activities (also contains a template for a Technical Agreement)
Guidance on the interpretation and implementation of European Good Distribution Practice Chapter 7 – Outsourcing

Chapter 2: Personnel
Guidance on the interpretation and implementation of European Good Distribution Practice Chapter 2 – Personnel

Chapter 5: Operations
Guidance on the interpretation and implementation of European Good Distribution Practice Chapter 5 – Operations

In order to better access the documents a new menu button has been added to the Members Area. Please login to download the documents of interest. In the Members Area you can also use the GDP Discussion Forum and the GDP Supplier Database. Please register here at no costs if you have not applied for membership yet.