《PIC-S验证指南》.pdf

PIC/S 2. INTRODUCTION The basic principles and application of qualification and validation are described in Annex 15 to the PIC/S and EU Guide to GMP. This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows: Ø Validation Master Plan Ø Installation and Operational Qualification Ø Non-Sterile Process Validation Ø Cleaning Validation The four Recommendations comprising this document