New Version 3.0 of ECA's GMP and GDP Q&As Guide published

Searching for concrete answers to GMP & GDP questions is a time-consuming activity. That's why the new and fully revised Version 03 of the GMP & GDP Question and Answer Guide document is intended to provide a single source of information. We have summarized GMP & GDP questions and answers from regulators around the world. Version 3.0. was released in September 2026.

The document is structured according to the organisations which have issued the Q&As: EMA/Europe, MHRA (UK), FDA (USA), ICH and from the ECA. The subject index of the document contains some of the “GMP & GDP Key Words” and enables the finding of Q&As addressing the relevant topic. It is intended to update this comprehensive collection and to also add new Q&As once they are available.

You can download the new Version 3.0 of the GMP & GDP Q&As free of charge here.