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
http://www.gmp-compliance.org/eca_gmp-guide.html
| GMP Question and Answer Guide „GMP Advisor“ |
| http://www.gmp-compliance.org/eca_gmp-guide.html |
| 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… |
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