EMA Reflection paper on the use of starting materials and intermediates collected from different sources, 02/12 DRAFT 2021-09-17T13:46:01+00:00November 20th, 2019|
EMA Questions and Answers: GMP Guide Part II API in Investigational Medicinal Products 2021-09-17T13:43:20+00:00November 20th, 2019|
EU Guidelines on the principles of GDP of active substances for medicinal products for human use (2015/C 95/01), 03/15 2021-09-17T14:03:49+00:00November 20th, 2019|
EU GMP Guide Part III, Guidelines on risk assessment for GMP for excipients of medicinal products for human use (2015/C 95/02), 03/15 2021-09-17T13:55:31+00:00November 20th, 2019|