Transcription of Quality Agreement for Laboratories Guideline Templates
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Quality Agreement for Laboratories Guideline Templates
_____ Copyright 2012 Active Pharmaceutical Ingredients Committee (APIC) ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) Quality Agreement for Laboratories Guideline & Templates _____ Copyright 2012 Active Pharmaceutical Ingredients Committee (APIC) Version April 2012 APIC Quality Agreement Guideline for Laboratories _____ Copyright 2012 Active Pharmaceutical Ingredients Committee (APIC) Version April 2012 Page 3/20 Disclaimer This document represents voluntary guidance for API manufacturers and their Contract Laboratories and the contents should not be interpreted as regulatory requirements. Alternative approaches than those described here may be used. Foreword The CEFIC* Sector Group APIC (the Active Pharmaceutical Ingredients Committee) was founded in 1992 as a direct consequence of the rapidly increasing European regulatory requirements affecting the manufacture of Active Pharmaceutical Ingredients (APIs).
APIC’s focus is on worldwide Quality, Good Manufacturing Practice (GMP) and Regulatory matters relating to APIs and intermediates. Through the years APIC has developed into a high-profile industry association with an excellent, worldwide reputation. APIC has already developed a series of guidance documents and position papers (see
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