1、變更控制ChangeControl文件編號DocumentNo.PO.QA.004版次Revision:A頁號Page:1/6起草者Author審核者Reviewedby批準者Approval生效日期Effectivedate復審日期NextreviewdateQA部SHEGM1、目的Purpose貫徹實施正式的書面的變更控制程序是為了有計劃地評價所有變更可能對中間體、最終產品質量和SHEt來的影響。Aformal,writtenchangecontrolprocedurewillbeimplementedandfollowedthatisdesignedtoevaluatedallchang

2、esthatmayaffecttheSHE,thequalityofintermediatesandfinalproduct.2、范圍Scope2.1 本規程適用于司。ThisprocedureisapplicabletoXinhua-Chemferm.2.2 該程序適用于公司各部門對已確立的所有程序所進行的變更。Thisprocedureisapplicabletoalldepartmentsestablisheddocumentforchanging.2.3 該規程適用于對產品質量或SHEW影響的工序或系統的變更，包括，但不限于：Thisprocedureappliestothechang

3、esthatinvolveeffectstotheproductsqualityortheSHEaspectsinthefollowingprocessand/orsystems,including,butnotlimited:2.3.1 原料和供應商，標準和有效期，工藝過程，分析方法，標簽和包材，設備,設施，輔助系統，計算機的硬件和軟件Rawmaterialsandsuppliers,Specificationsandvaliddate,Processsteps,Analyticalmethods,Labelingandpackagingmaterials,Equipment,Facilit

4、ies,內部使用Internaluse正式文件Official變更控制ChangeControl文件編號DocumentNo.PO.QA.004版次Revision:A頁號Page:2/6Supportsystems,Computerhardwareandsoftware.3、職責Responsibility1.1.5.0 總經理負責批準本程序。GMwillberesponsibletoapprovethiscompliancepolicy.Andapproveofmajorchanges.1.2.5.0 QA經理、SHE理負責執行與修訂本程序,QAmanagerandSHEmanagerwi

5、llberesponsibletoimplement,administerandupdatethiscompliancepolicyasnecessary.andtoapproveMinorchanges.1.3.5.0 所有部門經理負責執行本程序并報告發生的任何偏差。Alldepartmentmanagersareresponsibleforfollowingthisprocedureandreportinganydeviations.4、引用文件References4.1DAIpolicy0065、定義Definition微小變更：指對中間體及成品關鍵質量參數或對員工的安全、健康、環境方面

6、沒有可見影響的變更，用Level1表示。Minorchange:ChangeunlikelytohaveadetectableimpactonthecriticalqualityparametersoftheintermediateorActivePharmaceuticalIngredient(API)orthesafetyandhealthofemployee,orenvironmental.較大變更：指對中間體及成品關鍵質量參數或對員工的安全、健康、環境方面有可見影響的變更，用Level2表示。Majorchange:Changewhichmayhaveadetectableimpact

7、onthecriticalqualityparametersoftheintermediateorAPIorthesafetyandhealthofemployee,orenvironmental.臨時性變更：對產品質量或員工的安全、健康、環境的影響并不明確的一些臨時提出的變更。變更實施后不久可能會被終止或被永久性變更取代。變更控制ChangeControl文件編號DocumentNo.PO.QA.004版次Revision:A頁號Page:3/6Temporarychanges:Changestemporarilyproposedthathavenocertainimpactonproduc

8、tsquality,thesafetyandhealthofemployee,orenvironmental.Theymaybestoppedorreplacedbypermanentchanges.永久性變更：經證明確定不會影響產品質量或員工的安全、健康、環境的變更。變更實施后將一直保持到新的變更批準。Permanentchanges:Changesthathavebeenapprovedthathavenoimpactonproductquality,thesafetyandhealthofemployee,orenvironmental.Theywillbekeptontillnewch

9、angesareapproved.6、規程Procedure變更申請和批準：Changerequestandapprovalsteps變更申請者提出的變更申請、變更方案首先提交本部門經理審查并決定是否接受本申請。Firstofall,thechangeapplicationshouldbesenttothedepartmentmanagerforchecking,anddecidewhethertheapplicationisaccepted.變更提出部門以變更控制申請表的形式提出變更申請報QASHEM總經理,同時還應以附件方式詳細提出變更的理由、預期計劃和目標、相關資料以及執行人等內容。Th

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

11、ityforimplementation,monitoringthechange.變更提出部門組織召集有本部門和相關部門人員、SHEWQA&B門人員參加的專門會議共同按照SHEff核清單和GMPT核清單對變更進行評估并以文件的形式明確如何何時誰負責每一項具體行動。參加評估會議的人員在審核結論上簽變更控制ChangeControl文件編號DocumentNo.PO.QA.004版次Revision:A頁號Page:4/6字。ThedepartmentshouldcalltogetherthepeopleofSHE,QAanddepartmentinvolvedtoevaluatethechang

12、eaccordingtothechecklistofSHEandGMP,andshouldclearlyidentifyhow,whoandwhentheactionswillbedone,theevaluationshouldbedocumentedandsignedbyattendee.列入SHE審核清單和GMP審核清單的每一項行動應當按時完成并報告。TheactionslistedinSHE/GMPchecklistshouldbefinishedintimeandreport,6.1.5批準的變更申請由實施部門經理或授權人員根據計劃具體實施變更，同時啟動“變更啟動檢查表（附錄5）。Th

13、edepartmentmanagerortheauthorizedpeopleshouldcarrythechangeapplicationapprovedintoexecution,atthesametimefillintheappendix5TheAuthorizationFormofStartingChange:在非工作日發生的必須當天進行的緊急變更，由當班的負責人負責變更批準。如有疑問，可與相關部門的經理聯系，進行確認。緊急變更控制程序應同正常變更.Forthoseemergencychangethatmustbedoneinpresentnon-businessday,itwillb

14、eapprovedbypeopleonduty.Contactwithmanagerofrelateddepartmentifthereisanyquestionforconfirmation.Theprocedureofemergencychangeisthesameasnormal.變更的管理:Themanagementofchange變更完成后由變更實施授權人或部門經理寫出變更結果評價報告報SHE和QA批準。如果沒有提交該評價報告，則SHE和QA將在CIP中以不符合項的形式進行追蹤。Afterfinishedthestart-upofchange,theauthorizedpeopleo

15、rmanagerofthedepartmentinvolvedshouldcompleteanevaluationreportfortheproposedchangeafterbeingimplementedandsentittoSHEandQAforapproval.Iftheevaluationoftheresultsisnotsubmitted,itwillalwaysbeaviolationiteminCIP.內部使用Internaluse正式文件Official變更控制ChangeControl文件編號DocumentNo.PO.QA.004版次Revision:A頁號Page:5/

16、6SHE/QA批準變更結果評估報告后，該變更結束。ThechangeisendeduntilSHEandQAapprovethefinalevaluationreportofchange.QA給每一份變更一個單獨的編號，變更申請的全部原始文件由QA保存，QAwillissueaspecialserialnumberforeachapplication;theoriginaldocumentofchangeshouldbekeptinQA.QA/SHE經理每月分別以符合性改進計劃CIP方式上報總經理變更的進展及該程序的執行情況。Theimplementalsituationofchangewil

17、lbereporttoG.Mmonthlywithcomplianceimprovementplan(CIP)byQA/SHEmanagerrespectively.其他Others對經評估需進行驗證的較大變更，按驗證管理文件實施驗證。Forthemajorchangesthatneedvalidation,thevalidationwillbeimplementedaccordingtoitsdocuments.對可能影響成品有效期的較大工藝變更，應從生產中抽取有代表性的批號進行穩定性研究，重新評價產品的有效期。Forthosemajorprocesschangesthatmayhavein

18、fluencedshelf-lifeofproduct,representativebatchesshouldbetakenfromproductiontocarryoutastabilitystudy,andevaluatetheshelf-lifeagain.對于影響產品質量的較大變更，應及時將變更的情況通知公司的主要客戶。Forthosemajorchangesthatmayhaveinfluencedtoproductquality,thekeycustomersshouldbeinformedaboutthechange.7、附錄Annex附錄1：變更控制申請表Appendix1:Changeapplicationtable變更控制ChangeControl文件編號DocumentNo.PO.QA.004版次Revision:A頁號Page: