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 CLEANING PROCESS BRACKETING AND WORST CASE RATING Introduction Bracketing Procedure Cleaning Procedures Investigations and Worst Case Rating Worst Case Rating DETERMINATION OF THE AMOUNT OF RESIDUE Introduction Validation Requirements
based on the Threshold of Toxicological Concern (TTC), LD 50 and/or general cleaning limits may be calculated. In these cases, carcinogenic, genotoxic and potency effect of these structures should be evaluated by toxicologists. The acceptance criteria for equipment cleaning should be based on visually clean in dry ...
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