PIC S VMP 验证主计划(中英文对照).pdfVIP

RECOMMENDATIONS ON VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION STERILE PROCESS VALIDATION CLEANING VALIDATION (1/25) 1. DOCUMENT HISTORY Adoption by PIC/S Committee 10 - 11 December 1998 Entry into force of version PR 1/99-1 01 March 1999 Entry into force of version PI 006-1 01 September 2001 2. INTRODUCTION 2.1.2 本文件的目的在于给GMP审计人员提供一个指导 The basic principles and application of 文件，可用于培训和审计的准备工作。 qualification and validation are described 2.2 Scope of the document in Annex 15 to the PIC/S and EU Guide to GMP. 2.2.1 It is considered that the principles defined This document comprises individual Recommendations in the individual Recommendation documents can be on four topics relating to Equipment Qualification applied equally in the manufacture of active and Process Validation in pharmaceutical pharmaceutical ingredients (APIs) and finished manufacture, as follows: pharmaceuticals. Ø Validation Master Plan 2.2.2 At the time of issue, this document reflected Ø Installation and Operational Qualification the current state of the art. It is not intended to Ø Non-Sterile Process Validation be a barrier to technical innovation or the pursuit Ø Cleaning Validation of excellence. The four Recommendations comprising this document 2.2.3 The advice in these Recommendations is not define general principles pertaining to each of the