PIC S 验证指南(VMP，DQ,IQ,OQ,PQ中英文)[精品].doc

PIC/S验证指南 1. Document History 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: ? Validation Master Plan. ? Installation and Operational Qualification. ? Non-Sterile Process Validation. ? Cleaning Validation. The four Recommendations comprising this document define general principles pertaining to each of the topics. 2. 导言 PIC/S 和 EU GMP 指导原则的附录 15 中对确认(Qualification)和验证(Validation)的基本原则 及应用进行了阐述。 本文件包含了药物生产过中与设备确认和工艺验证相关的如下这四个方面的建议： 验证主计划 安装和运行确认 非无菌工艺验证 清洗验证 本文件中的建议确定了上述这四个方面的基本原则。 2.1 Purpose of the document 2.1.1 The topics of these Recommendation documents reflect some of the areas in pharmaceutical manufacture identified by both Inspectorates and the Pharmaceutical Industry as requiring guidance additional to that given in the current PIC/S GMP Guide. 2.1.2 The purpose of this document is to provide guidance for GMP inspectors in reviewing the issues covered to use for training purposes and in preparation for inspections. 2.1 本文件的目的 2.1.1 这些建议性文件的主题涉及的是那些审计人员和制药企业都认为需要对现行 PIC/S GMP 指导原则进行补充的领域。 2.1.2 本文件的目的在于给 GMP 审计人员提供一个指导文件，可用于培训和检查的准备工 作。 2.2 Scope of the document 2.2.1 It is considered that the principles defined in the individual Recommendation documents can be applied equally in the manufacture of active pharmaceutical ingredients (APIs) and finished pharmaceuticals. 2.2.2 At the time of issue, this document reflected the current state of the art. It is not intended to be a barrier to technical innovation or the pursuit of excellence. 2.2.3 The advice in these Recommendations