变更控制Changecontrol

1、变更控制ChangeControl文件编号DocumentNo.PO.QA.004版次Revision:A页号Page:1/6起草者Author审核者Reviewedby批准者Approval生效日期Effectivedate复审日期NextreviewdateQA部SHEGM1、目的Purpose贯彻实施正式的书面的变更控制程序是为了有计划地评价所有变更可能对中间体、最终产品质量和SHEt来的影响。Aformal,writtenchangecontrolprocedurewillbeimplementedandfollowedthatisdesignedtoevaluatedallchang

2、esthatmayaffecttheSHE,thequalityofintermediatesandfinalproduct.2、范围Scope2.1 本规程适用于司。ThisprocedureisapplicabletoXinhua-Chemferm.2.2 该程序适用于公司各部门对已确立的所有程序所进行的变更。Thisprocedureisapplicabletoalldepartmentsestablisheddocumentforchanging.2.3 该规程适用于对产品质量或SHEW影响的工序或系统的变更，包括，但不限于：Thisprocedureappliestothechang

3、esthatinvolveeffectstotheproductsqualityortheSHEaspectsinthefollowingprocessand/orsystems,including,butnotlimited:2.3.1 原料和供应商，标准和有效期，工艺过程，分析方法，标签和包材，设备,设施，辅助系统，计算机的硬件和软件Rawmaterialsandsuppliers,Specificationsandvaliddate,Processsteps,Analyticalmethods,Labelingandpackagingmaterials,Equipment,Facilit

4、ies,内部使用Internaluse正式文件Official变更控制ChangeControl文件编号DocumentNo.PO.QA.004版次Revision:A页号Page:2/6Supportsystems,Computerhardwareandsoftware.3、职责Responsibility1.1.5.0 总经理负责批准本程序。GMwillberesponsibletoapprovethiscompliancepolicy.Andapproveofmajorchanges.1.2.5.0 QA经理、SHE理负责执行与修订本程序,QAmanagerandSHEmanagerwi

5、llberesponsibletoimplement,administerandupdatethiscompliancepolicyasnecessary.andtoapproveMinorchanges.1.3.5.0 所有部门经理负责执行本程序并报告发生的任何偏差。Alldepartmentmanagersareresponsibleforfollowingthisprocedureandreportinganydeviations.4、引用文件References4.1DAIpolicy0065、定义Definition微小变更：指对中间体及成品关键质量参数或对员工的安全、健康、环境方面

6、没有可见影响的变更，用Level1表示。Minorchange:ChangeunlikelytohaveadetectableimpactonthecriticalqualityparametersoftheintermediateorActivePharmaceuticalIngredient(API)orthesafetyandhealthofemployee,orenvironmental.较大变更：指对中间体及成品关键质量参数或对员工的安全、健康、环境方面有可见影响的变更，用Level2表示。Majorchange:Changewhichmayhaveadetectableimpact

7、onthecriticalqualityparametersoftheintermediateorAPIorthesafetyandhealthofemployee,orenvironmental.临时性变更：对产品质量或员工的安全、健康、环境的影响并不明确的一些临时提出的变更。变更实施后不久可能会被终止或被永久性变更取代。变更控制ChangeControl文件编号DocumentNo.PO.QA.004版次Revision:A页号Page:3/6Temporarychanges:Changestemporarilyproposedthathavenocertainimpactonproduc

8、tsquality,thesafetyandhealthofemployee,orenvironmental.Theymaybestoppedorreplacedbypermanentchanges.永久性变更：经证明确定不会影响产品质量或员工的安全、健康、环境的变更。变更实施后将一直保持到新的变更批准。Permanentchanges:Changesthathavebeenapprovedthathavenoimpactonproductquality,thesafetyandhealthofemployee,orenvironmental.Theywillbekeptontillnewch

9、angesareapproved.6、规程Procedure变更申请和批准：Changerequestandapprovalsteps变更申请者提出的变更申请、变更方案首先提交本部门经理审查并决定是否接受本申请。Firstofall,thechangeapplicationshouldbesenttothedepartmentmanagerforchecking,anddecidewhethertheapplicationisaccepted.变更提出部门以变更控制申请表的形式提出变更申请报QASHEM总经理,同时还应以附件方式详细提出变更的理由、预期计划和目标、相关资料以及执行人等内容。Th

10、echangeshouldputforwardaapplicationwithform,asattachmentthewrittenreportsshouldbeprovidedtoQA,SHEandG.Mbythedepartmentatonetime.Thereportsshouldincludebutnotlimitedtothefollowing:thechangereasons,relatedprotocolandtarget,relatedinformationanddata,anditshouldalsoclearlyidentifyhowwhohastheresponsibil

11、ityforimplementation,monitoringthechange.变更提出部门组织召集有本部门和相关部门人员、SHEWQA&B门人员参加的专门会议共同按照SHEff核清单和GMPT核清单对变更进行评估并以文件的形式明确如何何时谁负责每一项具体行动。参加评估会议的人员在审核结论上签变更控制ChangeControl文件编号DocumentNo.PO.QA.004版次Revision:A页号Page:4/6字。ThedepartmentshouldcalltogetherthepeopleofSHE,QAanddepartmentinvolvedtoevaluatethechang

12、eaccordingtothechecklistofSHEandGMP,andshouldclearlyidentifyhow,whoandwhentheactionswillbedone,theevaluationshouldbedocumentedandsignedbyattendee.列入SHE审核清单和GMP审核清单的每一项行动应当按时完成并报告。TheactionslistedinSHE/GMPchecklistshouldbefinishedintimeandreport,6.1.5批准的变更申请由实施部门经理或授权人员根据计划具体实施变更，同时启动“变更启动检查表（附录5）。Th

13、edepartmentmanagerortheauthorizedpeopleshouldcarrythechangeapplicationapprovedintoexecution,atthesametimefillintheappendix5TheAuthorizationFormofStartingChange:在非工作日发生的必须当天进行的紧急变更，由当班的负责人负责变更批准。如有疑问，可与相关部门的经理联系，进行确认。紧急变更控制程序应同正常变更.Forthoseemergencychangethatmustbedoneinpresentnon-businessday,itwillb

14、eapprovedbypeopleonduty.Contactwithmanagerofrelateddepartmentifthereisanyquestionforconfirmation.Theprocedureofemergencychangeisthesameasnormal.变更的管理:Themanagementofchange变更完成后由变更实施授权人或部门经理写出变更结果评价报告报SHE和QA批准。如果没有提交该评价报告，则SHE和QA将在CIP中以不符合项的形式进行追踪。Afterfinishedthestart-upofchange,theauthorizedpeopleo

15、rmanagerofthedepartmentinvolvedshouldcompleteanevaluationreportfortheproposedchangeafterbeingimplementedandsentittoSHEandQAforapproval.Iftheevaluationoftheresultsisnotsubmitted,itwillalwaysbeaviolationiteminCIP.内部使用Internaluse正式文件Official变更控制ChangeControl文件编号DocumentNo.PO.QA.004版次Revision:A页号Page:5/

16、6SHE/QA批准变更结果评估报告后，该变更结束。ThechangeisendeduntilSHEandQAapprovethefinalevaluationreportofchange.QA给每一份变更一个单独的编号，变更申请的全部原始文件由QA保存，QAwillissueaspecialserialnumberforeachapplication;theoriginaldocumentofchangeshouldbekeptinQA.QA/SHE经理每月分别以符合性改进计划CIP方式上报总经理变更的进展及该程序的执行情况。Theimplementalsituationofchangewil

17、lbereporttoG.Mmonthlywithcomplianceimprovementplan(CIP)byQA/SHEmanagerrespectively.其他Others对经评估需进行验证的较大变更，按验证管理文件实施验证。Forthemajorchangesthatneedvalidation,thevalidationwillbeimplementedaccordingtoitsdocuments.对可能影响成品有效期的较大工艺变更，应从生产中抽取有代表性的批号进行稳定性研究，重新评价产品的有效期。Forthosemajorprocesschangesthatmayhavein

18、fluencedshelf-lifeofproduct,representativebatchesshouldbetakenfromproductiontocarryoutastabilitystudy,andevaluatetheshelf-lifeagain.对于影响产品质量的较大变更，应及时将变更的情况通知公司的主要客户。Forthosemajorchangesthatmayhaveinfluencedtoproductquality,thekeycustomersshouldbeinformedaboutthechange.7、附录Annex附录1：变更控制申请表Appendix1:Changeapplicationtable变更控制ChangeControl文件编号DocumentNo.PO.QA.004版次Revision:A页号Page: