New Q&As on Chapter 4 and 5 of the EU-GDP Guidelines

On the GDP Association Website a section was set up a while ago dealing with frequently asked questions (FAQs). Now a set of new FAQs has been published on Chapter 4 (Documentation) and Chapter 5 (Operations).

For example, the following questions are discussed:

  • Who authors documents? Who needs to approve them?
  • In which language should documents be written?
  • Is it allowed to print procedures from an electronic system?
  • How can I check if a supplier has an appropriate legal authorisation?
  • Besides temperature, are there other environmental factors which might harm medicinal products?
  • Why do I need to qualify customers?

Answers to these and other questions are provided in the new FAQs on GDP.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.