Transcription of ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE …
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ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE …
1 For Internal Use Only Revision April 2019 (updated in February 2021) ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS 2 For Internal Use Only Table of Contents FOREWORD OBJECTIVE SCOPE ACCEPTANCE CRITERIA Introduction Methods of Calculating Acceptance Criteria Acceptance criteria using health-based data Acceptance criteria using a General Limit Acceptance criteria for therapeutic macromolecules and peptides Swab Limits Rinse Limits Rationale for the use of different limits in PHARMACEUTICAL and chemical production LEVELS OF CLEANING Introduction Cleaning Levels Cleaning Verification/Validation CONTROL OF
Note: for therapeutic macromolecules and peptides the determination of HBEL using PDE limits of the active and intact product may not be required (conform EMA CHMP/ CVMP/ SWP/169430/2012). An alternative approach is suggested in section 4.2.3.
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