GMP Question & Answer Guide
The requirements defined in the GMP Guidelines often leave room for interpretation. However, regulators worldwide (EMA, FDA, TGA etc) sometimes publish frequently asked questions on GMP. In a new ECA document these Q&As are summarized in a single source. The Q&As are structured in 4 main GMP Areas (General GMPs, GMP for APIs, GMP for Medicinal Products, GMP for IMPs). The document contains 150 pages of Q&As and is available at no cost on the ECA Webpage. A first set of ECA Q&As have also been included and additional GMP Q&As are planned for the future. Here you can access the GMP Questions and Answers Guide
|GMP Question and Answer Guide „GMP Advisor“|
|Searching for concrete answers to GMP questions is a time-consuming activity. The document we now offer is intended to provide a single source of information. We have summarized GMP questions and answers from regulators around the world.
In addition to EMA, FDA, Health Canada, MHRA (UK), TGA (Australia) and ICH, we have also used Q&As from ECA. The subject index of the document contains some of the “GMP 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.
The document is structured into the 4 main GMP areas: General GMPs (applicable to medicinal products, APIs and IMPs), GMP for Medicinal Products, GMP for APIs and GMP for Investigational Medicinal Products (IMPs). In addition,it is indicated which organization has issued the Question and Answers. You can access and download the GMP Q&A Guide here
Please see the table of contents below:
1. General GMPs
2. GMP for Medicinal Products
3. GMP for APIs
4. GMP for IMPs