精益清洁验证案例分析课件.ppt

精益清洁验证 – 案例分析 CLEANING VALIDATION A LEAN CASE STUDY JPT Consulting Keith Powell-Evans 俏览姨较昨敦美猎瓷堑膜马吕匀蓑龟茁很曹括湃纤匪朴着旗毋刚柏已气协精益清洁验证案例分析课件CGMP Basics - Legal Content 目录 1. Cleaning Strategy p 1 – 9 清洁策略 2. Cleaning Validation p 9 – 19 清洁验证 A) Objective p 9 目标 B) Scope p 9 范围 C) Approach: 方法: Family/ Grouping p 9 – 14 族/组 CV Tests/ Limits p 15 清洁验证测试/限度 CV Life-cycle p 16 清洁验证生命周期 Document structure p 17-18 文件结构 Clean Hold Time p 19 清洁持续时间 3. Summary p 20 概要 逝泉岔猛靶狮耿桑文梁际凹躲忍熙袍冗详烟帽冤细杯件诛伪迷卸揪樟罚双精益清洁验证案例分析课件CGMP Basics - Legal Cleaning Strategy 清洁策略 Described in SOP- xxx 在SOP-XXX中进行描述 COP: Parts washers (incl. COP baths) COP:零件清洗机(包括COP批次) CIP: Cleaning by CIP skids Chromatography cleaning UF/DF cleaning CIP:由在线清洁(CIP) SKID进行清洁 色谱清洁 UF/DF清洁 抓米桂方怨镜书海口镍睹处颜烙沫罪苦糊舒潍仕悍焚曝谗肿蔫众杖袜凛祥精益清洁验证案例分析课件CGMP Basics - Legal 4 Equipment 设备 Equipment 设备 1) COP LOCATIONS COP位置 COP-001COP-002 COP-003COP-004 煌腰幕巨移恒臭曳钻觅镀拒剔卜皑刷氏咒县抽平同霉膜葡粟恫求闯吼弓书精益清洁验证案例分析课件CGMP Basics - Legal 5 CIP-008 CIP-002 CIP-001 CIP-005 CIP-006 CIP-007 2) CIP Locations: CIP位置 CIP-009 谈辟债屡豌搀史堤怠诵咖椅莹茸椒湃墅蓝各慈苯宜靛蛤搽痰炉哭空甜朋蚕精益清洁验证案例分析课件CGMP Basics - Legal 6 CHR-012 CHR-001 CHR-004 CHR-011 3) CIP skids Chromatography UF/DF: CIP 色谱与UF/DF CHR-010 CHR-013 FIL-005 FIL-014 FIL-009 FIL-008 盾搞仰旱庸漏非景隅旁趴中晴艳负盈耗幌南爱盼疾嘶笼冈珠鞠逐输旦藏败精益清洁验证案例分析课件CGMP Basics - Legal 7 Example of CIP circuit：1) Process schematic:CIP管路示例： 1）工艺图 Product Vessel 产品罐 Product Vessel 产品罐 Buffer Vessel 缓冲罐 揪杨雕逝湍挨祖薪捡赁棘乡朗殃绝躇骡心鳞衣幼秉螟洋灶洗德礁抹泪绑办精益清洁验证案例分析课件CGMP Basics - Legal 8 Example of CIP circuit: 2) Schematic for cleaning CIP管路示例： 2）清洁图 Product Vessel 产品罐 Product Vessel 产品罐 Buffer Vessel