AS-H15安瓿灭菌器SOP101..doc

PHARMACHINE 安瓿灭菌器 AS-H1.5 AMPOULE AUTOCLAVE 1.5M3 性能确认 PERFORMANCE QUALIFICATION (PQ) （文件仅供客户参考，以实物为准，可做修改） (This document is only reference for users, use real goods as standards,can do corresponding amendment ) 性能确认方案确认表 APPROVAL DOCUMENT OF PQ PROTOCOL 描述：Description 本文件由用户和 商贸有限公司双方共同确认。 This document is the approval of the protocol from both parties PHARMACHINE CHINA LTD. and user. 本文件仅适用于下面所述项目。 This documentation only applies to the project below described. 没有 商贸有限公司同意，本文件不得被复制或提供给第三方。 The documentation must not be reproduced or given to third parties without being written allowed by 。 设备名称： Equipment: 设备型号： Equipment Type: 设备编号： Equipment NO 协议批准Protocol Approval: 标题Title 名字Name 签名Signature 日期Date Prepared by 工程师 Project Engineer 复核人 wed by 主管 Director 批准人Approved by 客户质量主管 Customer Director of Quality and Regulatory 审核人 Approved by 客户技术经理 Customer Technical Manager 文件协调员 Document Coordinator 客户确认 Customer Validation 协议完成（签名后，协议就完全完成了） Protocol Completion (To be signed only after protocol has been completed): 标题Title 名字Name 签名Signature 日期Date 执行人员 Executed By: 客户工程测试员 Customer testing engineers 审核 人员 Approved by 客户质量主管 Customer Director of Quality and Regulatory 审核 人员 Approved by 客户技术经理 Customer Technical Manager 文件协调员 Document Coordinator 客户确认 Customer Validation A 目录Table of Contents 1、性能确认 Performance qualification summary………………….5 1.1性能确认前的检查inspection before performance qualification 1.2控制程序确认CONTROL PROCEDURE CONFIRMATION………………… 1.3性能确认小结 PERFORMANCE QUALIFICATION BRIEF SUMMARY…… 附1设备确认报告Appendix 1 equipment validation report 附2偏差单Appendix 2 Non conformity List 1、性能确认（PQⅠ） Performance qualification(PQⅠ) summary （性能确认文件需使用方自行根据实际情况制定本文件仅提供参考performance qualification documents need user according to real circs to make,this document is only for reference） 安瓿灭菌器性能确认目的是证明本机对生产的适用性Ampoule autoclave performance q