GMP/GDP Question and Answer Guide – New Version 3.0. - September 2026
Searching for concrete answers to GMP & GDP questions is a time-consuming activity. The 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.
Total Number of Pages: 230
1. EMA (EU)
1.1 Questions and Answers on GMP and GDP
1.2 Questions & answers on quality of herbal medicinal products/traditional herbal medicinal products
1.3 Questions and answers (version 22) - Safety features for medicinal products for human use
2. Technical Specifications of the Unique Identifier
3. General Provision on the Verification and Decommissioning of the Safety Features
2. European Commission (EU)
Questions and Answers on Importation of APIs
3. MHRA (UK)
Questions and Answers on GMP for Investigational Medicinal Products
4. FDA (USA)
Questions and Answers on cGMP Requirements
5. ICH
Questions and Answers on ICH Q7, Q8, Q9 and Q10
6. ECA Academy
6.1 Questions and Answers on Visual Inspections
6.2 Questions and Answers on Good Distribution Practices (GDP)
6.3 Questions and Answers on Data Integrity
6.4 Bioburden – Regulatory Expectations and Practical Experiences Q&As