3变更控制管理规程文档格式.docx

1、设施 FaCilities.公用系统（如水系统、压缩空气系统等）UtiIitieS （e.g Water system, COmPreSSed air SySteml etc.）产品生产工艺 ManUfaCtUring PrOCeSSeS清洁工艺 CIeaning MethOdS质量标准 SPeCifiCatiOnS检验方法 AnalytiCal TeSt MethOdS计算机硬件和软件 COmPUter HardWare and SOftWare生产地址 ManUfaCtUnng Site2.2本规程不包括文件变更。文件变更按照文件管理规程执行。ThiS PrOCedUre excludes

2、 the Change COntrOl Of documents WhiCh is described in MDOCUment Management”.2.3本规程不包括供应商变更。供应商变更按照供应商评估与选择管理规程执行。ThiS PrOCedUre excludes the Changes in SUPPNerS WhiCh is governed Under USUPPlier EVaIUatiOn and Selection.2.4本规程不包括标签和包装材料变更。标签和包装材料变更按照产品包装设汁、印 刷管理规程执行。ThiS PrOCedUre excludes the Chan

3、ges in IabeIS and PaCkaging materials WhiCh are governed Under IlManagement Of PaCkaging Matenal DeSign & Printingl3职责/Responsibilities3.1 变更申请人/Applicant Of Change提出变更申请 RaiSe the Change application提供变更申请和变更实施所需的支持性材料PrOVide SUPPOrting materials for application and implementation Of change.拟定变更的实施日

4、期 PrOPOSe the implementation date参加与所提交变更相关的评估会议PartiCiPate in the assessment meeting regarding the Change编写风险评估报告（如需要）Generate a risk assessment report if required制定变更实施计划，跟踪变更进度EStabIiSh the Change implementation PIanl track Change SChedUle3.2生产车间/Workshop评估变更对产品质量的影响EValUate the impact On PrOdUCt

5、 quality评估变更对本部门GMP文件的影响EVaIUate the impact On the associated departments GMP documentation3.3国际部/International Dept.a） 评估对国外客户的影响 EValUate the impact On foreign CUStOmerSb） 评佔对国外注册资料的影响 EValUate the impact On the foreign registration file3.4物流部/Logistics DePartment评估对物料/产品存储、发运的影响EValUate the impac

6、t On StOrage and distribution Of Matenal/productEValUate the impact On the associated departments GMP documentatiOn3.5研发中心/Research& DeVelOPment Center评估对注册资料的影响 EValUate the impact On the registration file执行注册补充申请工作（如需要）PrePare and SUbmit the SUPPlementary registratiOn document to the COmPetent aut

7、hority Where applicable3.6公共支持部/Utilities SUPPOrt评估对变更设备运营和维护保养的影响EValUate the impact On the OPeratiOn and maintenance Of equipment to beChanged3.7销售中心、销售部/Sales Center& SaleS Dept.评佔包装变更带来的市场影响性EVaIUate the impact On the market CaUSed by the Change Of PaCkaging material OrIabeI3.8安全环保部/EHS DePartme

8、nt评佔安全隐患和废弃物带来的环境污染的影响性EValUate the POtential Safety risk and ImPaCt On the environ merit CaUSed by WaStage resulting from Change3.9生产运营部/Production DePartment评佔对产品的工艺规程和生产计划的影响EValUate the impact Of the Change On the PrOCeSS inStrUCtiOnand PrOdUCtiOn Plan3.10质量控制部 ZQUality COntrOl评估变更后的检验方法、质量标准的适用

9、性EValUate the SUitabiIity Of analytical test methods and SPeCifiCatiOn if the Change is impleme nted评估是否需要附加的试验EValUate Whether need additional experiment Or not3.11质量管理部/Quality Management发放变更编号 ISSUe an OffiCial number for the Change评估对验证状态的影响，决定是否需要验证EValUate the impact On the ValidatiOn StatUS a

10、nd determine Whether ValidatiOn is required Or not评估对产品质量的潜在影响EValUate the POtential impact On the PrOdUCt quality评估变更对地方药监局和客户的影响EValUate the impact On the IOCal authorities Or IOCal CUStOmerS对变更进行分级ClaSSify the ChangeS决定是否对变更进行风险评估Determine Whether there is a need to PerfOrm a risk assessment for

11、the PrOPOSed Change审核质量风险评估 ReVieW quality risk assessment保证变更流程符合此规程EnSUre that the PrOCeSS Of Change is in COmPliance With this PrOCedUre批准/拒绝变更 APPrOVe/Reject the Change3.12质量负责人/Head Of QUaIity批准/拒绝关键变更APPrOVe/Reject the CntiCal Change4定义/Definition4.1关键变更：对中间体或产品有潜在重大质量风险的变更。通常需要进行生产试验、 确认、验证及必

12、要的质量研究。关键变更包括但不仅限于：CntiCal changes: Refer to Changes that have Significant POtential quality risk On the intermediate Or the product. A PrOdUCtiOn trial, qualification, VaIidatiOn Or necessary quality StUdieS Will be required for this type Of Change. CritiCal ChangeS include but are not Iimited to:改

13、变工艺路线或者关键工艺参数Change Of PrOCeSS route Or CntiCal PrOCeSS ParameterS工艺中引入新的溶媒、溶剂、物料AdditiOn Of new SOlVentS and materials改变关键的中间控制参数 Change Of key in PrOCeSS COntrOl ParameterS改变起始物料、中间体或者成品质量标准的限度Change in SPeCifiCati On for Starti ng materials, in termediates Orfi nished PrOdUCtS改变分析方法 Change Of analytical methods生产及质量管理用计算机系统变更Change Of COmPUtenZed SyStem USed in PrOdUCtiOn & quality management改变灭菌工艺 MOdifiCatiOn Of StenIiZatiOn PrOCeSS改变发酵用生产菌种（指主细胞库）MOdifiCatiOn Of Strain USed in fermentation PrOCeSS （i.e master Ce