Eudralex Volume 3 Guideline on Manufacture of the Finished Dosage Form

Title:
Eudralex Volume 3 Guideline on Manufacture of the Finished Dosage Form

https://www.gmp-compliance.org/files/guidemgr/guideline-manufacture-finished-dosage-form-revision-1_en.pdf

Origin/Publisher:

EMA

Document Type:
Guideline
Content:
The note for guidance(CPMP/QWP/486/95)has been updated to reflect the requirements as laid down in the current legislation Directive 2001/83/EC, and to follow the format and content of the Common Technical Document (CTD) Module 3 dossier. It also addresses current manufacturing practices in terms of complex supply chains and worldwide manufacture. In addition, the content and principles of the ICH Q8 guideline are also taken into account.

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