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Eudralex Volume 10 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
These guidelines lay down appropriate tools to address specific issues concerning investigational medicinal products with regard to good manufacturing practice. The tools are flexible to provide for changes as knowledge of the process increases and appropriate to the stage of development of the product.