FDA清洁的验证检查指南.docVIP

GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s). I. INTRODUCTION Validation of cleaning procedures has generated considerable discussion since agency documents, including the Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide, have briefly addressed this issue. These Agency