Transcription of GUIDELINE for QUALIFICATION & MANAGEMENT …
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GUIDELINE for QUALIFICATION & MANAGEMENT …
ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) GUIDELINE for QUALIFICATION & MANAGEMENT of CONTRACT QUALITY CONTROL LABORATORIES 10 January 2012 2 Content 1. Introduction 2. Chapter 1: Identification of Potential Laboratories 3. Chapter 2: Risk Assessment 4. Chapter 3: Quality Assessment 5. Chapter 4: Ongoing Contract Laboratory MANAGEMENT (Monitoring and Evaluation) Appendices Appendix 1: Contract Laboratories Potential Identification Selection Appendix 2: Contract Laboratories Questionnaires Appendix 3: Risk Assessments Tool 3 INTRODUCTION Over the last decade the pharmaceutical industry has made a dramatic shift in how it is outsourcing many activities that historically would never have been anticipated before.
6 If the specifications for the test results are communicated to the contract laboratory by the contract giver then an OOS procedure must be in place, and in the event of an out of
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