Transcription of GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN …
{{id}} {{{paragraph}}}
Example: barber
GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN …
CONFIDENTIAL 1 Revision September 2016 active pharmaceutical ingredients COMMITTEE (APIC) GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN active pharmaceutical INGREDIENT PLANTS CONFIDENTIAL 2 Table of Contents FOREWORD OBJECTIVE SCOPE ACCEPTANCE CRITERIA Introduction Methods of Calculating Acceptance Criteria Acceptance criteria using health-based data Acceptance criteria based on Therapeutic Daily Dose Acceptance criteria based on LD50 General Limit as acceptance criteria 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 Worst Case Rating DETERMINATION OF THE AMOUNT OF RESIDUE Introduction VALIDATION Requirements Sampling Methods Analytical Methods CLEANING VALIDATION PROTOCOL Background
The subject of cleaning validation in active pharmaceutical ingredient manufacturing plants has continued to receive a large amount of attention from regulators, companies and customers alike. The integration of Cleaning Validation within an effective Quality System supported by ... recommended as a valuable guidance document from industry.
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: