Quality Management System
Quality Management System for Active pharmaceutical Ingredients manufacturers Integrating GMP into ISO 9001 December 1997
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SUPPLIER QUALIFICATION & MANAGEMENT …
www.apic.cefic.orgactive pharmaceutical ingredients committee (apic) supplier qualification & management guideline december 2009
Template TaskForce Computer validation - apic.cefic.org
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Additional guidance on the assessment on the risk ...
www.apic.cefic.orgThe API risk assessment should be reviewed and updated as applicable. - Use scientific knowledge or literature to obtain information (synthesis pathway, etc.) - Use alternative source of information (website, audit report…) 2.3. Risk assessment EFPIA decision tree [4] is a helpful tool to undertake the risk assessment.
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