在线监测系统要求.pdfVIP

THE PHARMACEUTICAL AND HEALTHCARE SCIENCES SOCIETY BEST PRACTICE FOR PARTICLE MONITORING IN PHARMACEUTICAL FACILITIES Technical Monograph No. 16 CONTENTS PAGE 目录 1 Foreword 1、前言 2 Acknowledgments 6 2 、确认 3 Introduction 73、介绍 4 Air particle monitoring to EU GMP Annex 1:2008 84 、欧盟GMP 中关于空气粒子监测的附件 5 System design 145、系统设计 6 Operations 256、操作 7 Maintenance and Cleaning 307、保养和清洁 8 Disaster Recovery and Data Back-up 328、容灾恢复和数据备份 9 Training 339、培训 10 Appendix A - Worked example of monitoring system layout . . . 3410、附件A ：监控系统布局的成功案例 11 Appendix B - Manifold and remote particle monitoring systems 3611、附件B ：集成和远程粒子监控系统的案例 12 Appendix C - Examples of particle loss in transport tubing 3912、附件C ：管道输送中粒子损失的案例 13 Appendix D - Isokinetic probes 4213、附件D ：等动力采样头 14 Appendix E - Validation and risk assessment standards and guidelines 4314、附件E ：验证和风险评估的标准 与指导方针 1 FOREWORD 前言 The Pharmaceutical and Healthcare Sciences Society (PHSS) exists as a science based forum for individuals active in the fields of Pharmaceutical and Healthcare Sciences. The society evolved from the former Parenteral Society, which was primarily focused on sterile injectable and implantable drugs and devices, to meet the needs of a wider community and broaden its horizons and membership, with the change of name effective from 1 March 2006. 制药科学和保健学会（PHSS ）是研究制药和保健学科，由活跃在制药和保健行业的专家组成的以科学为依 据的社会团体。学会前身为注射剂协会，关注无菌注射剂和植入式药品和器械。为适应更多团体的需求， 拓展会员并拓宽研究范围，学会从2006 年3 月1 日起改名为制药科学和保健学会（PHSS ） The PHSS objectives are: PHSS 的宗旨和目标是： 1. To foster and advance, in the interest of public health, pharmaceutical and healthcare science and practice. 促进和提高制药科学和保健领域的发展； 2. To provide and disseminate to its members information concerning all aspects of pharmaceutical technology and administration of medicines. 向会员提供和传播各种制药以及给药技术信息 3. To identify specific areas where there is a need for new information or the co