The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

APIC - eCTD How to do Document

Origin/Publisher:

CEFIC - Active Pharmaceutical Ingredients Committee (APIC), Av. E. Van Nieuwenhuyse 4 / box 2, B - 1160 Brussels, Tel: +32 (0)2 676 72 11, www.cefic.org

Document Type:
APIC Industry Best practice document
Content:
This document provides guidance on how to document API quality in the eCTD.

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