1、變更控制ChangeControl文件編號(hào)DocumentNo.PO.QA.004版次Revision:A頁號(hào)Page:1/6起草者Author審核者Reviewedby批準(zhǔn)者Approval生效日期Effectivedate復(fù)審日期NextreviewdateQA部SHEGM1、目的Purpose貫徹實(shí)施正式的書面的變更控制程序是為了有計(jì)劃地評(píng)價(jià)所有變更可能對(duì)中間體、最終產(chǎn)品質(zhì)量和SHEt來的影響。Aformal,writtenchangecontrolprocedurewillbeimplementedandfollowedthatisdesignedtoevaluatedallchang

2、esthatmayaffecttheSHE,thequalityofintermediatesandfinalproduct.2、范圍Scope2.1 本規(guī)程適用于司。ThisprocedureisapplicabletoXinhua-Chemferm.2.2 該程序適用于公司各部門對(duì)已確立的所有程序所進(jìn)行的變更。Thisprocedureisapplicabletoalldepartmentsestablisheddocumentforchanging.2.3 該規(guī)程適用于對(duì)產(chǎn)品質(zhì)量或SHEW影響的工序或系統(tǒng)的變更，包括，但不限于：Thisprocedureappliestothechang

3、esthatinvolveeffectstotheproductsqualityortheSHEaspectsinthefollowingprocessand/orsystems,including,butnotlimited:2.3.1 原料和供應(yīng)商，標(biāo)準(zhǔn)和有效期，工藝過程，分析方法，標(biāo)簽和包材，設(shè)備,設(shè)施，輔助系統(tǒng)，計(jì)算機(jī)的硬件和軟件Rawmaterialsandsuppliers,Specificationsandvaliddate,Processsteps,Analyticalmethods,Labelingandpackagingmaterials,Equipment,Facilit

4、ies,內(nèi)部使用Internaluse正式文件Official變更控制ChangeControl文件編號(hào)DocumentNo.PO.QA.004版次Revision:A頁號(hào)Page:2/6Supportsystems,Computerhardwareandsoftware.3、職責(zé)Responsibility1.1.5.0 總經(jīng)理負(fù)責(zé)批準(zhǔn)本程序。GMwillberesponsibletoapprovethiscompliancepolicy.Andapproveofmajorchanges.1.2.5.0 QA經(jīng)理、SHE理負(fù)責(zé)執(zhí)行與修訂本程序,QAmanagerandSHEmanagerwi

5、llberesponsibletoimplement,administerandupdatethiscompliancepolicyasnecessary.andtoapproveMinorchanges.1.3.5.0 所有部門經(jīng)理負(fù)責(zé)執(zhí)行本程序并報(bào)告發(fā)生的任何偏差。Alldepartmentmanagersareresponsibleforfollowingthisprocedureandreportinganydeviations.4、引用文件References4.1DAIpolicy0065、定義Definition微小變更：指對(duì)中間體及成品關(guān)鍵質(zhì)量參數(shù)或?qū)T工的安全、健康、環(huán)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(duì)中間體及成品關(guān)鍵質(zhì)量參數(shù)或?qū)T工的安全、健康、環(huán)境方面有可見影響的變更，用Level2表示。Majorchange:Changewhichmayhaveadetectableimpact

7、onthecriticalqualityparametersoftheintermediateorAPIorthesafetyandhealthofemployee,orenvironmental.臨時(shí)性變更：對(duì)產(chǎn)品質(zhì)量或員工的安全、健康、環(huán)境的影響并不明確的一些臨時(shí)提出的變更。變更實(shí)施后不久可能會(huì)被終止或被永久性變更取代。變更控制ChangeControl文件編號(hào)DocumentNo.PO.QA.004版次Revision:A頁號(hào)Page:3/6Temporarychanges:Changestemporarilyproposedthathavenocertainimpactonproduc

8、tsquality,thesafetyandhealthofemployee,orenvironmental.Theymaybestoppedorreplacedbypermanentchanges.永久性變更：經(jīng)證明確定不會(huì)影響產(chǎn)品質(zhì)量或員工的安全、健康、環(huán)境的變更。變更實(shí)施后將一直保持到新的變更批準(zhǔn)。Permanentchanges:Changesthathavebeenapprovedthathavenoimpactonproductquality,thesafetyandhealthofemployee,orenvironmental.Theywillbekeptontillnewch

9、angesareapproved.6、規(guī)程Procedure變更申請(qǐng)和批準(zhǔn)：Changerequestandapprovalsteps變更申請(qǐng)者提出的變更申請(qǐng)、變更方案首先提交本部門經(jīng)理審查并決定是否接受本申請(qǐng)。Firstofall,thechangeapplicationshouldbesenttothedepartmentmanagerforchecking,anddecidewhethertheapplicationisaccepted.變更提出部門以變更控制申請(qǐng)表的形式提出變更申請(qǐng)報(bào)QASHEM總經(jīng)理,同時(shí)還應(yīng)以附件方式詳細(xì)提出變更的理由、預(yù)期計(jì)劃和目標(biāo)、相關(guān)資料以及執(zhí)行人等內(nèi)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(guān)部門人員、SHEWQA&B門人員參加的專門會(huì)議共同按照SHEff核清單和GMPT核清單對(duì)變更進(jìn)行評(píng)估并以文件的形式明確如何何時(shí)誰負(fù)責(zé)每一項(xiàng)具體行動(dòng)。參加評(píng)估會(huì)議的人員在審核結(jié)論上簽變更控制ChangeControl文件編號(hào)DocumentNo.PO.QA.004版次Revision:A頁號(hào)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(xiàng)行動(dòng)應(yīng)當(dāng)按時(shí)完成并報(bào)告。TheactionslistedinSHE/GMPchecklistshouldbefinishedintimeandreport,6.1.5批準(zhǔn)的變更申請(qǐng)由實(shí)施部門經(jīng)理或授權(quán)人員根據(jù)計(jì)劃具體實(shí)施變更，同時(shí)啟動(dòng)“變更啟動(dòng)檢查表（附錄5）。Th

13、edepartmentmanagerortheauthorizedpeopleshouldcarrythechangeapplicationapprovedintoexecution,atthesametimefillintheappendix5TheAuthorizationFormofStartingChange:在非工作日發(fā)生的必須當(dāng)天進(jìn)行的緊急變更，由當(dāng)班的負(fù)責(zé)人負(fù)責(zé)變更批準(zhǔn)。如有疑問，可與相關(guān)部門的經(jīng)理聯(lián)系，進(jìn)行確認(rèn)。緊急變更控制程序應(yīng)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(shí)施授權(quán)人或部門經(jīng)理寫出變更結(jié)果評(píng)價(jià)報(bào)告報(bào)SHE和QA批準(zhǔn)。如果沒有提交該評(píng)價(jià)報(bào)告，則SHE和QA將在CIP中以不符合項(xiàng)的形式進(jìn)行追蹤。Afterfinishedthestart-upofchange,theauthorizedpeopleo

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

16、6SHE/QA批準(zhǔn)變更結(jié)果評(píng)估報(bào)告后，該變更結(jié)束。ThechangeisendeduntilSHEandQAapprovethefinalevaluationreportofchange.QA給每一份變更一個(gè)單獨(dú)的編號(hào)，變更申請(qǐng)的全部原始文件由QA保存，QAwillissueaspecialserialnumberforeachapplication;theoriginaldocumentofchangeshouldbekeptinQA.QA/SHE經(jīng)理每月分別以符合性改進(jìn)計(jì)劃CIP方式上報(bào)總經(jīng)理變更的進(jìn)展及該程序的執(zhí)行情況。Theimplementalsituationofchangewil

17、lbereporttoG.Mmonthlywithcomplianceimprovementplan(CIP)byQA/SHEmanagerrespectively.其他Others對(duì)經(jīng)評(píng)估需進(jìn)行驗(yàn)證的較大變更，按驗(yàn)證管理文件實(shí)施驗(yàn)證。Forthemajorchangesthatneedvalidation,thevalidationwillbeimplementedaccordingtoitsdocuments.對(duì)可能影響成品有效期的較大工藝變更，應(yīng)從生產(chǎn)中抽取有代表性的批號(hào)進(jìn)行穩(wěn)定性研究，重新評(píng)價(jià)產(chǎn)品的有效期。Forthosemajorprocesschangesthatmayhavein

18、fluencedshelf-lifeofproduct,representativebatchesshouldbetakenfromproductiontocarryoutastabilitystudy,andevaluatetheshelf-lifeagain.對(duì)于影響產(chǎn)品質(zhì)量的較大變更，應(yīng)及時(shí)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(qǐng)表Appendix1:Changeapplicationtable變更控制ChangeControl文件編號(hào)DocumentNo.PO.QA.004版次Revision:A頁號(hào)Page: