EMA Eudralex Volume 4 Annex 13 – Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014
https://health.ec.europa.eu/document/download/a0b206a0-5788-406b-9e20-e0525b16e712_en?filename=guideline_adopted_1_en_act_part1_v3.pdf