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 - Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers - Integrating GMP (ICH Q7a) into ISO (9001:2000), September 2005
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 gives detailed guidance for implementing a QMS and provides a standard for API manufacturers.
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