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).
A Quality Agreement under the scope of this guideline is a legally binding agreement that is mutually negotiated and concluded between (the Quality Departments of) the service requestor and the Quality responsible at the service providing laboratory.
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