博世設(shè)備文件電子版iq-hql

1、Table of 參考文獻(xiàn) 4引4范圍4Test philosophyTestapproach測(cè)試結(jié)構(gòu) Test structureTest5566667o be所t test Table of 參考文獻(xiàn) 4引4范圍4Test philosophyTestapproach測(cè)試結(jié)構(gòu) Test structureTest5566667o be所t test 777變更控制 Change Test 888nelTest 8術(shù)語(yǔ)表9附錄9721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical

2、, Shijiazhuang, QD|IQ|IQ參考文獻(xiàn) 引This Installation Qualification (IQ) ch equipment installed at CSPC Pharmaceutical, Shijiazhuang, China. The execution of and its 參考文獻(xiàn) 引This Installation Qualification (IQ) ch equipment installed at CSPC Pharmaceutical, Shijiazhuang, China. The execution of and its 3. 本

3、文件包含了IQ 計(jì)劃以及相關(guān)必要 721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, 標(biāo) Order SOP-AG-08.008c:Selectionofscriticalnonformatsystem ationforSOP-AG-06.011c: Qualification deviation SOP-AG-24.004c: Procedure for change SOP-AG-09.009c: Verification of proscrit

4、icalComponentswithdirectimpactto the Product Quality IQQD|IQ|IQtshowschHQL3680,721635hasbeencorrectlyIQ Thetest resultsoftheIQwill beapprovedafterexecutionwith 4. Test ThefollowingchapterdescribesingeneralthetestphilosophyforthisTest tshowschHQL3680,721635hasbeencorrectlyIQ Thetest resultsoftheIQwil

5、l beapprovedafterexecutionwith 4. Test ThefollowingchapterdescribesingeneralthetestphilosophyforthisTest TheobjectiveofthisIQistogathertt ch IQ 計(jì)劃是根據(jù)文件1和文件2GMP cGMP 的要求。代表批準(zhǔn)。在測(cè)試并且關(guān)閉所有不符合項(xiàng)之后，IQ測(cè)試TheIQplanhasbeenproducedaccordingto1andtheagreedscopeofsupplyin2,which PCOuyiPharmaceuticalives.Aftertesti

6、ngandclosingofthethe IQ report will be ed and approved ch and CSPC Pharmaceutical chisresponsibleforthetestexecution.TheIQtestswillbeperformedaftercompletiontheequipmen CSPCOuyiPharmaceuticalpremisesaccordingtotheagreedAllinformationforanindividualtestwillbeattachedthecorrespondingtestsheets.Testati

7、onwillbeattachedas IQhescopeoftheIQ,shallbeaccordingto。Thedrawings,sketches,datasheetsetc.whichareusedfortestexecutionwillbeaddedtoindividualtestsheetsandedwiththetest達(dá)成一致的測(cè)試的接受標(biāo)準(zhǔn)已在測(cè)試范圍內(nèi)定義（見(jiàn)第五章和Appendix The agreed acceptance criteria for each test are defined Appendix 附錄 2).附錄 2）he test scope (see c

8、hapter 5 721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQThe havethefollowingTitle of testTestnumberTest run no.Test Test Test Acceptance The havethefollowingTitle of testTestnumberTest run no.Test Test Test Acceptance ttestactions(ifTestCom

9、ments Final test Test The procedure for executing each Appendix 附錄 2).he test table (see chapter TestIfapplicable,theprerequisitesofeachtestarehetest所數(shù)據(jù)o beA specification of data which should be retained as vant test procedure.edevidenceishe 721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I

10、 CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQ測(cè)試后續(xù)措t test Incaseactionsneedtoconsideredortakenaftertestexecutiontheyaredefined test procedure.he是Duringtestexecutionsingletest resultshave to becompared with theexpected results,andsto測(cè)試后續(xù)措t test Incaseactionsneedtoconsideredortakenaftertestexecuti

11、ontheyaredefined test procedure.he是Duringtestexecutionsingletest resultshave to becompared with theexpected results,andstobemadeforeachacceptancecriteriaywhethertheresult(yes)or not以測(cè)試的最終判定結(jié)束測(cè)試。如果滿足所有接受標(biāo)準(zhǔn)， “ A final assessment shall close a test. “Results comply: Yes” (Passed) shall be used if all a

12、ccep- tancecriteriahavebeenmet.Incaseoneormoreacceptance criteriacannotbemetthe test shall be assessed as failed (“Results comply: No”).每項(xiàng)測(cè)試（或再測(cè)試）的最終結(jié)論也在測(cè)試范圍內(nèi)（見(jiàn)第五章5 / Appendix 附2).附錄 2）測(cè)試表格中手寫(xiě)的數(shù)據(jù) 、備注、修改和簽名應(yīng)該根據(jù)文件4來(lái)操作。在測(cè)試執(zhí)行完成后，將測(cè)試數(shù)據(jù)填寫(xiě)在測(cè)試表格中。正常情況下, 任何手寫(xiě)數(shù)據(jù)的修改都由填寫(xiě)數(shù)據(jù)的人修改。執(zhí)行驗(yàn)證使用的每頁(yè)文件Data entries, comments,

13、 corrections and signatures by hand onto theprepared test sheet be performed in accordance with 4. Data is to be o as executed. Any correction to handwritten data should normally be made by the thedata.Eachpageusedforexecutingthequalificationistobesignedanddated.到a test data sheet provided the respo

14、nsible author signs the data sheet. For calculation some datashouldbetransferredtocomputerandthecalculationpr edandthenattachedtoatest 使用Appendix 附3 中的次要偏差日志/All tarediscoveredduringexecutionaretobeothedeficiencieslogdeviationssheetaccordingto 5 usingthe deficiency sheetor thedeviation sheetin 附7216

15、35I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQ Thedeficiency/deviationsheetsarecollected IQ folder.變更控制 Change 在安裝確認(rèn)過(guò)程中，文件（包括測(cè)試詳細(xì)信息）和設(shè)備必須嚴(yán)格根據(jù)文件6，使用Appendix附4中的DuringtheIQ (includingtestingdetails)andallequipment Thedeficiency/deviationsheetsar

16、ecollected IQ folder.變更控制 Change 在安裝確認(rèn)過(guò)程中，文件（包括測(cè)試詳細(xì)信息）和設(shè)備必須嚴(yán)格根據(jù)文件6，使用Appendix附4中的DuringtheIQ (includingtestingdetails)andallequipmentmustbeunderstrictchangecontrolaccordingto6usingtheforminAppendix 附All change control formsused are he IQ changecontrol chapterof the IQ Test Thes usoftheIQexecutionand

17、thefollowupactionsaftercompletionoftheIQareshownnel本文件中確認(rèn)活動(dòng)涉及的所將列在附錄 1的表中nel he qualification activities ofwill be listed using tableofAppendix附nelThecompletedlistwillbeheestingchapteroftheIQ5. Test 所有IQ 測(cè)試的測(cè)試步驟和接受標(biāo)準(zhǔn)在附錄 2的表格中列出。Alistofteststobeperformedincludingthetestproceduresandacceptancecriteria

18、tobeduringtheIQarehetableofAppendix 附在測(cè)試執(zhí)行完成之后， 每項(xiàng)測(cè)試的最終結(jié)果也包括在該表格內(nèi)，收錄在 IQAftertestexecutionthecompletedtablewillalsohetestscopechapteroftheIQhefinalresultforeachtestand721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQ術(shù)語(yǔ)表附錄如果在測(cè)試執(zhí)行過(guò)程中需要使用附錄中的測(cè)試表

19、格需要復(fù)印一份, a copy shall be taken for manual entries Ifareusedduringthetesttestrecordingtheoriginalwillalwaysbe術(shù)語(yǔ)表附錄如果在測(cè)試執(zhí)行過(guò)程中需要使用附錄中的測(cè)試表格需要復(fù)印一份, a copy shall be taken for manual entries IfareusedduringthetesttestrecordingtheoriginalwillalwaysbeheIQ721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 368

20、0 I CSPC Ouyi Pharmaceutical , Shijiazhuang, Appendix附錄IdentificationofnelAppendix附錄Test Appendix附錄次要偏差表/偏差Deficiency Sheet / Deviation Appendix附錄ChangecontrolCheckof確認(rèn)機(jī)器關(guān) scriticalMachineVerificationofthesflowCheckInstallation ISO 61346-Reference designation according to ISO 61346-tag (EMSR-電氣儀表和控制

21、依據(jù)DIN Standard Operatingn.a.ornotQD|IQ|IQIdentificationofnel。nelhequalificationactivitiesofthis he relevant data sheet.willbehebelowand721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, 職位/公司itionIdentificationofnel。nelhequalificationactivitiesofthis h

22、e relevant data sheet.willbehebelowand721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, 職位/公司ition / 日簽縮QD|IQ|IQ The The contains 3721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQ: : The conta

23、ins 2721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQAppendix4: 變更Change control Appendix4: 變更Change control The contains1721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQAppendix 5.1

24、: 檢查公Check of Appendix 5.1: 檢查公Check of The contains 3721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQAppendixVerificationof s critical Machine AppendixVerificationof s critical Machine The contains 2721635I721635_HQL.docIRev.1.0Ien 6ch Pack

25、aging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQsflowsflowThe contains 2721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQAppendix5.4: 檢查Check sThe Appendix5.4: 檢查Check sThe contains 2721635I721635_HQL.docIRev.1.0Ien 6ch Pack

26、aging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQIQ IQ HQL除熱原滅菌隧道Sterilizing 石歐意藥業(yè)Ouyi 中國(guó)，石家莊721635IQ IQ HQL除熱原滅菌隧道Sterilizing 石歐意藥業(yè)Ouyi 中國(guó)，石家莊721635I721635_HQL.docIRev.1.0Ien 6ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, QD|IQ|IQ Alist ofteststobeperformedinclud

27、ingthetestproceduresandacceptancecriteriatobeusedduring Alist ofteststobeperformedincludingthetestproceduresandacceptancecriteriatobeusedduringtheIQareheelow.Afterexecutionthis tablewill also hefinalresultforeach721635I721635_HQL.doc IRev.1.0Ien1ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shi

28、jiazhuang, 測(cè)Test 測(cè)試項(xiàng)目Test 接受標(biāo)準(zhǔn)Acceptance 偏差/次要偏差Results comply 備測(cè)再測(cè)試1CheckofAllconnectedcomponentsmustbe uniquely identifiable.Theyhavetobeconnectedtothere- levant media supply systems pro- No deviations betnactualcon- nection dimens and design, thesemightcompromisetheindivi- dual pro721635I721635_H

29、QL.doc IRev.1.0Ien1ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, 測(cè)Test 721635I721635_HQL.doc IRev.1.0Ien1ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, 測(cè)Test 測(cè)試項(xiàng)目Test 接受標(biāo)準(zhǔn)Acceptance 偏差/次要偏差Results comply 備測(cè)再測(cè)試2Verification of scritical “已設(shè)計(jì)Compliance betn the par

30、t list (asdesigned)andthemechanical (asbuilt)regardingtodesigndata, nent labeling.3s flow Compliance betn the proflowdiagram(asdesigned)andma- chine(asbuilt).Allcomponentsare 裝。All components in piare in- he right sequence.721635I721635_HQL.doc IRev.1.0Ien1ch Packaging HQL 3680 I CSPC Ouyi Pharmaceu

31、tical ,721635I721635_HQL.doc IRev.1.0Ien1ch Packaging HQL 3680 I CSPC Ouyi Pharmaceutical , Shijiazhuang, 測(cè)Test 測(cè)試項(xiàng)目Test 接受標(biāo)準(zhǔn)Acceptance 偏差/次要偏差Results comply 備測(cè)再測(cè)試4Checks可用性s listedhe order confirmation areavailablecified languages and the specified number of copies.hasthecorrectnum- ber of pages, a

32、ll chapters listed in the table of contents are present, and all attaents are present. appearstobewith- outobvious failures (this is a check of thestructureandnot the textual details).721635_HQL 3680_SOP-AG-12.007ec.doc | Rev. 7.0 ch Packaging Yes No Date Initials Results comply ResultsapprovedTest

33、results YesNo721635_HQL 3680_SOP-AG-12.007ec.doc | Rev. 7.0 ch Packaging Yes No Date Initials Results comply ResultsapprovedTest results YesNoAcceptance criteria Theyhavetobeconnectedtotherelevantmedia supply systems properly.Nodeviationsbet nactualconnectiondimen s anddesign, these mightcompromise

34、theindividual pro s.Comments Test identification MarkwithXorn.a.Testobjectiveto a re tall media supplysystemsareuniquelyidenti- tems properly.Moreoveradditionalinformationshouldbegatheredontheasbuilt dimen s and compared to the design.Test prerequisites 機(jī)器型號(hào)HQL Machineno機(jī)Test location 測(cè)試場(chǎng)地list 文件列表其

35、它CSPC Ouyi Verification of utilities 確認(rèn)公Page1 /TestprocedureTest number IQ721635_HQL 3680_SOP-AG-12.007ec.doc | Rev. 7.0 ch Packaging Comments / Date Initials 721635_HQL 3680_SOP-AG-12.007ec.doc | Rev. 7.0 ch Packaging Comments / Date Initials CommentbyCSPC Ouyi Verification of utilities 確認(rèn)公Page2 /T

36、estprocedureTest number IQ721635_HQL 3680_SOP-AG-12.007ec.doc | Rev. 7.0 ch Packaging Utility Result 721635_HQL 3680_SOP-AG-12.007ec.doc | Rev. 7.0 ch Packaging Utility Result Date/AsNotok. CSPC Ouyi Verification of utilities 確認(rèn)公Page3 /TestprocedureTest number IQ721635_HQL p_machine.doc | Rev.9.0 ch

37、 Packaging Yes / /Date Initials Results comply ResultsapprovedTest results YesNoAcceptance criteria721635_HQL p_machine.doc | Rev.9.0 ch Packaging Yes / /Date Initials Results comply ResultsapprovedTest results YesNoAcceptance criteria Compliancebetnthepartlist(asdesigned)and (asbuilt)regardingtodes

38、igndata,itemdesignation (BmKz) and component labeling.Comments Test identification MarkwithXorn.a.Testobjectiveto atcriticalcomponentsareinstalled correctlyat ationandthemechanical electrical Test prerequisites 機(jī)器型號(hào)HQL Machineno機(jī)Test location 測(cè)試場(chǎng)地list 文件列表其它CSPC Ouyi Verification of ProComponents /確

39、認(rèn)機(jī)Page1 /TestprocedureTest number IQ721635_HQL p_machine.doc | Rev.9.0 ch Packaging Comments / Date Initials 721635_HQL p_machine.doc | Rev.9.0 ch Packaging Comments / Date Initials CommentbyCSPC Ouyi Verification of ProComponents /確認(rèn)機(jī)Page2 /TestprocedureTest number IQ721635_HQL 3680_SOP-AG-.doc|Rev

40、.9.0ch Packaging Yes / /Date Initials Results comply ResultsapprovedTest results YesNo Acceptance 721635_HQL 3680_SOP-AG-.doc|Rev.9.0ch Packaging Yes / /Date Initials Results comply ResultsapprovedTest results YesNo Acceptance criteria Compliancebetn the prosflowdiagram(as designed) and machine (as

41、built).All components areAll components in piare installedheright Comments Test identification MarkwithXorn.a.TestobjectiveThistestincludesaverificationofthe All mentionedsystems shouldbecharacterized.Anasbuilt - as designed check is foreseen in order to verifyttherightcomponent has been installed a

42、t the right sequence.Test prerequisites 機(jī)器型號(hào)HQL Machineno機(jī)Test location 測(cè)試場(chǎng)地list 文件列表其它CSPC Ouyi VerificationofthesFlowDiagram確認(rèn)工Page1 /TestprocedureTest number IQ721635_HQL 3680_SOP-AG-.doc|Rev.9.0ch Packaging Comments / Date 721635_HQL 3680_SOP-AG-.doc|Rev.9.0ch Packaging Comments / Date Initials

43、CommentbyCSPC Ouyi VerificationofthesFlowDiagram確認(rèn)工Page2 /TestprocedureTest number IQ721635_HQL 3680_SOP-AG-03.001ec.doc | Rev. 1.0 ch Packaging Yes / /DateInitialsResults comply ResultsapprovedTest results YesNo 721635_HQL 3680_SOP-AG-03.001ec.doc | Rev. 1.0 ch Packaging Yes / /DateInitialsResults

44、comply ResultsapprovedTest results YesNo Acceptance criteria Availability:alls listedhe order confirmation are availablehespecifiedlanguages and the specified number of copies.Completeness: eachhas the correct number of pages, all chapters listedhetableof contents are present, and all attaents are Obvious failures: eachappearstobe without obvious failures (this is a check of thestructureandnotthetextualdetails).Comments Test identification MarkwithXorn.a.Testobjectiveto checkswithhe scope supply of the order confirmation, include the ava