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 Sampling Methods Analytical Methods
Acceptance criteria using health-based data 4.2.2 Acceptance criteria using a General Limit 4.2.3. ... are performed in such a way that risks to patients related to cleaning validation are understood, ... Possible risk are for example contra-indications, possible allergens, risk for children, previous products that should not be taken daily ...
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