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制药设备与工艺验证
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第1章验证概述1 1.1验证的发展史1 1.1.1引言1 1.1.2验证的由来1 1.1.3验证的定义2 1.1.4验证的意义4 1.2基于生命周期的验证流程4 1.2.1基于设备类系统生命周期的验证流程5 1.2.2基于产品工艺生命周期的验证流程6 1.2.3基于全生命周期的验证流程活动7 1.3风险管理在验证活动中的应用17 1.3.1法规要求18 1.3.2质量风险管理实施流程18 1.3.3质量风险管理工具21 1.3.4质量风险管理在产品生命周期验证活动中的应用24 1.4验证管理体系搭建和验证总计划35 1.4.1验证团队建立35 1.4.2验证管理体系36 1.4.3验证总计划37 1.4.4验证文件管理47 本章小结51 参考文献51 第2章设备/设施/系统确认与验证52 2.1洁净环境系统确认52 2.1.1洁净室52 2.1.2空调净化系统概述及确认57 2.1.3洁净环境系统73 2.1.4洁净环境日常监测77 2.2公用工程系统确认80 2.2.1公用工程系统简介80 2.2.2制药用水系统80 2.2.3制药用蒸汽系统89 2.2.4工艺气体系统90 2.2.5公用工程系统确认93 2.2.6公用工程系统持续监测100 2.3制药工艺设备确认100 2.3.1制药设备简介100 2.3.2GMP对设备的管理要求102 2.3.3典型的工艺设备介绍及确认104 2.4辅助设备确认122 2.4.1热力灭菌知识122 2.4.2法规指南对灭菌的要求124 2.4.3热力灭菌设备介绍126 2.4.4湿热灭菌设备126 2.4.5干热灭菌设备134 本章小结136 参考文献136 第3章计算机化系统验证与数据可靠性138 3.1计算机化系统验证138 3.1.1计算机化系统生命周期139 3.1.2计算机化系统软硬件分类141 3.1.3计算机化系统质量风险管理143 3.1.4新建计算机化系统验证——基于风险的可增减的生命周期活动148 3.1.5遗留计算机化系统验证简介150 3.2数据可靠性154 3.2.1数据可靠性管理策略155 3.2.2数据生命周期157 3.2.3质量管理体系下的数据可靠性管理164 本章小结167 参考文献167 第4章QC实验室确认与验证168 4.1分析仪器确认168 4.1.1分析仪器确认的法规要求170 4.1.2分析仪器分类及确认策略171 4.1.3分析仪器确认实施通则171 4.1.4实验室工作软件验证概略173 4.1.5分析仪器确认实例174 4.2分析方法验证175 4.2.1GMP对分析方法验证和确认的要求175 4.2.2分析方法验证流程和文件176 4.2.3方法生命周期内的验证活动177 4.2.4分析方法转移192 4.2.5分析方法生命周期内持续符合性确认193 本章小结194 参考文献194 第5章工艺程序验证196 5.1消毒与灭菌效果验证196 5.1.1消毒与灭菌概述196 5.1.2消毒与灭菌的化学方法应用198 5.1.3消毒与灭菌的化学方法验证199 5.1.4消毒与灭菌的物理方法应用204 5.1.5消毒与灭菌的物理方法验证205 5.1.6消毒与灭菌效果的持续监管206 5.2无菌工艺模拟208 5.2.1无菌工艺模拟法规指南要求208 5.2.2先决条件209 5.2.3无菌生产工艺的风险评估与差条件选择209 5.2.4模拟试验过程的干预设计210 5.2.5模拟介质的选择210 5.2.6无菌工艺模拟设计211 5.2.7培养条件212 5.2.8可接受标准与结果评价212 5.2.9无菌工艺模拟试验的周期与再验证212 5.3清洁验证213 5.3.1清洁验证概述213 5.3.2清洁程序开发阶段213 5.3.3清洁验证设计阶段219 5.3.4清洁验证实施阶段228 5.3.5清洁验证状态的维护228 5.4工艺验证229 5.4.1工艺验证的定义229 5.4.2工艺验证的一般原则229 5.4.3传统工艺验证230 5.4.4基于生命周期的工艺验证232 5.5包装验证242 5.5.1包装定义242 5.5.2包装验证概述243 5.5.3包装验证法规要求243 5.5.4包装设备确认244 5.5.5包装完整性验证254 5.6仓储与运输验证258 5.6.1简介258 5.6.2仓储验证259 5.6.3运输验证262 5.6.4仓储及运输再验证265 本章小结266 参考文献266 第6章制药工艺验证267 6.1原料药工艺验证267 6.1.1原料药工艺流程概述267 6.1.2原料药工艺风险评估270 6.1.3原料药工艺验证要点271 6.2口服固体制剂工艺验证276 6.2.1口服固体制剂工艺流程概述277 6.2.2口服固体制剂工艺风险评估279 6.2.3口服固体制剂工艺验证要点283 6.3无菌制剂工艺验证284 6.3.1无菌制剂工艺流程概述284 6.3.2无菌制剂工艺设计要素286 6.3.3无菌制剂工艺风险评估290 6.3.4无菌制剂工艺验证要点292 6.4生物制品工艺验证292 6.4.1生物制品的分类292 6.4.2单克隆抗体生产的工艺流程293 6.4.3单克隆抗体生产的工艺设备302 6.4.4单克隆抗体生产工艺验证的风险评估309 6.4.5单克隆抗体药物的生产原液工艺验证部分要点312 6.5中药工艺验证313 6.5.1中药生产工艺流程概述313 6.5.2中药生产工艺设计316 6.5.3中药工艺风险评估318 6.5.4中药工艺验证要点319 本章小结323 参考文献323 第7章制药工艺验证支持活动324 7.1良好工程质量管理324 7.1.1良好工程质量管理规范的概念324 7.1.2GEP的基本内容325 7.1.3GEP的范围326 7.1.4GEP的阶段性管理要求327 7.1.5GEP的文件管理需求329 7.2培训329 7.2.1培训的目的330 7.2.2培训的内容分类330 7.2.3培训流程330 7.2.4培训相关文件331 7.3校准与计量332 7.3.1法规要求332 7.3.2校准管理332 7.3.3仪器仪表校准一般要求335 7.3.4常见问题336 7.4验证测试仪器336 7.4.1验证测试仪器概述336 7.4.2验证测试仪器使用案例341 7.5变更和偏差346 7.5.1变更控制和偏差管理的意义346 7.5.2验证中的变更控制346 7.5.3验证中的偏差管理348 7.6统计分析技术351 7.6.1统计分析技术概述351 7.6.2描述性统计分析及其应用352 7.6.3统计过程控制及其应用357 7.6.4实验设计与分析及其应用362 本章小结368 参考文献368
制药工艺验证是实施药品GMP的重要基础,也是制药企业贯彻采用质量管理体系的重要组成部分。特别是近些年来,我国制药行业快速发展,各种制药相关法规、指南相继发布,国内的验证标准逐渐和国际接轨,呈现趋同化。为了提高我国制药行业的发展水平,满足《国家中长期教育改革和发展规划纲要(2010—2020)》和《国家中长期人才发展规划纲要(2010—2020)》中“强调要培养一大批创新能力强、适应经济社会发展需要的高质量各类型工程技术人才,为国家走新型工业化发展道路、建设创新型国家和人才强国战略服务”的需求,本书编者团队基于多年从事验证工作的丰富经验,为帮助普通高等院校和国内制药企业快速而高效地培养一批验证工程技术人员,秉承“推动行业进步”的发展使命,依据中国、欧盟、WHO和美国等国家和组织的GMP和监管要求,参考ICH、ISO、ISPE、PIC/S等有关实践指南,基于以下重要原则编写本书: ·强调“生命周期”概念; ·强调“质量源于设计”(Quality by Design, QbD); ·强调对产品和工艺需求的理解; ·强调产品保护; ·强调关键质量属性(Critical Quality Attribute, CQA)和关键工艺参数(Critical Process Parameter, CPP)的重要性; ·采用基于风险评估的方法; ·综合国际现行GMP法规对确认与验证的要求; ·包含良好工程管理规范(Good Engineering Practice, GEP)概念; ·贯穿全书的验证案例分析。 本书内容涉及制药行业中原料药、固体制剂、无菌制剂、生物制剂和中药生产的工艺设备、公用设施、辅助设备、计算机化系统的验证工作;同时涵盖了风险管理、实验室系统、数据可靠性、清洁验证及工艺验证等国内制药行业重点关注的主题。从理论和实际两个方面,以验证对象特性和验证原理作为起始,将前沿的验证理念与具体的验证实践相结合,归纳总结为以下7章内容:验证概述;设备/设施/系统确认与验证;计算机化系统验证与数据可靠性;QC实验室确认与验证;工艺程序验证;制药工艺验证;制药工艺验证支持活动。为在当今GMP法规环境要求下基于先进的风险评估理念进行确认与验证工作,提供了非常有价值的实践经验。在内容方面,体现了不同验证对象的验证原理,解决了验证活动中“为什么?做什么?如何做?”的问题。关于验证原理的任何描述均是对验证活动的必要铺垫和补充。在章节安排方面,不同章节间可能有重复的内容,这种重复是必要的,有助于更好地了解验证活动。在术语和缩略语方面,本书编者尽可能采用了国际通行的确认与验证术语和缩略语,由于翻译或引用国外法规指南和著作的局限性,以及目前国内制药行业术语应用的普遍性,在描述专业性上可能存在差异,请各位读者及同行批评指正。 本书由资深GMP专家、制药业内同行和高等院校老师共同编写,由马义岭、郭永学担任主编,王云宝、孙聪聪担任副主编。全书编写的具体分工如下:第1章由焦玉秀、佟丽、孙聪聪、宋新星、杨娟、任志会共同编写;第2章由袁泽琪、吕宗敏、赵红霞、石天鹏、李贵香、于恒宾、于红想、雷杰、周备共同编写;第3章由郭明刚、王良、尹子彬共同编写;第4章由刘世博、方建茹、郑树朝共同编写;第5章由陈永波、殷丽杰、钟守炜、甄兴航、李基、赵原、于红想共同编写;第6章由殷丽杰、赵洪军、王勇、孙聪聪、张帆共同编写;第7章由王勇、葛丹、郭明刚、于红想、焦玉秀、周玮、王世华、叶振亚、杨海泉、郑树朝共同编写;参与审稿的人员有:承强、罗文华、马仕洪、庞红宁、王焱、徐菲、喻长远、于庆华、臧恒昌、张功臣、赵赟力;全书由马义岭、孙聪聪、郑树朝、陈永波统稿。 本书仅反映了在该书出版之前编者对GMP法规、指南和行业标准指导下的验证活动理解,尽可能以浅显易懂的方式,完整且详细地介绍制药企业基于全生命周期的确认与验证活动。由于时间仓促,又限于编者水平,书中难免有不妥和疏漏之处,我们衷心希望高校老师和制药行业的广大同仁不吝赐教、批评指正。 编者 2018年9月
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