药品生产企业GMP培训 的环境监测.ppt

Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. 环境监测 Valadon only. ith Aspose slides for NET 4o client P Evaluation only. Created with Aspose Slides for NET 4.0 Client Profile 171 Copyright 2004 -2017 Aspose Pty Ltd  Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. 环境监测 一、环境监测基本概念 二、环境监控方案的制定 法规要求和检查重点 Vaudon only. ith Aspose slides for NET 4o client P Evaluation only. Created with Aspose Slides for NET 4.0 Client Profile 171 Copyright 2004 -2017 Aspose Pty Ltd  Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. 环境监测-文献 USP1116 USP1115 Sterile Drug Products Produced by Aseptic Processing PDA-13 Fundamentals of a Microbiological Environmental Monitoring Program S0-14661-1 GMP附录1 GB162921629316294 EU GMP Vaudon only. ith Aspose slides for NET 4o client P Evaluation only. Created with Aspose Slides for NET 4.0 Client Profile 171 Copyright 2004 -2017 Aspose Pty Ltd  Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. Evaluation only. Created with Aspose.Slides for .NET 4.0 Client Profile 17.1. Copyright 2004-2017Aspose Pty Ltd. 环境监测一概念 目的:环境监测可帮助建立一个有针对性的、易于管理和有预防功 能的程序。 为确保稳定的生产环境,全面的环境控制程序应包括以下方面: 合理的厂房设计和维护 b.文件系统 c.已验证/确认的卫生清洁/消毒程序 d.可靠的过程控制 e.良好的设备管理和保养 f.进入洁净区的有效控制 g.有效的培训,证书/资格以及评估程序 h.物料及设备的质量保证 环境监测是一种评估对生产环境控制的有效性的具 Vaudon only. ith Aspose slides for NET 4o client P Evaluation only. Created with Aspose Slides for NET 4.0 Cl