博世設(shè)備文件電子版iq-rru

1、IQ 計(jì)劃IQ PlanRRU 2033自動(dòng)洗瓶機(jī)Automatic Washing Machine721634石藥藥業(yè)CSPC Ouyi Pharmaceutical Co.,中國(guó)，石家莊Shijiazhuang, China博世批準(zhǔn)的 IQ 計(jì)劃（執(zhí)行前）IQ Plan approval bych (before execution)721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, Chi

2、na職責(zé)FunctionName職位/ 公司ition / Company簽名Signature日期Date起草Created byZhang ZhaomingQualification Engineer, ch PackagingTechnology(Hangzhou)Co.,.審核Reviewed byXu HuiQualification Engineer, ch PackagingTechnology(Hangzhou)Co.,.批準(zhǔn)Approved byAdrian DanihlikDepartment head, SVC, ch PackagingTechnology(Hangzh

3、ou)Co.,.QD | IQ | IQ Plan1/9批準(zhǔn) IQ 計(jì)劃（執(zhí)行前）石藥藥業(yè)IQ Plan approval by CSPC Ouyi Pharmaceutical Co.,(before execution)history文檔歷史721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, China1.026.Aug.2013Create from template.Zhang Zhao

4、ming版本Rev.日期Date描述Description作者Author職責(zé)FunctionName職位/ 公司ition / Company簽名Signature日期Date批準(zhǔn)Approved by批準(zhǔn)Approved by批準(zhǔn)Approved byQD | IQ | IQ Plan2/9目錄 Table of Contents1.參考文獻(xiàn) Referen42.引言roduction43.范圍 Scope44.4.14.24.34.44.54.64.74.84.94.104.114.12測(cè)試方法 Test philosophy測(cè)試途徑 Test approach 測(cè)試結(jié)構(gòu) Test st

5、ructure 測(cè)試程序 Test procedure測(cè)試前提 Test prerequisites5566667777888數(shù)據(jù) Dao be recorded所需測(cè)試后續(xù)措施t test actions Test results文件書(shū)寫(xiě)和備注 Handwritten entries and comments偏差處理 Deviation handling變更控制 Change control測(cè)試總結(jié) Test summarynel involvedesting測(cè)試涉及的5.測(cè)試范圍 Test scope86.術(shù)語(yǔ)表 Glossary97.附錄 Appendix9721634 I 721634

6、_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan3/91.參考文獻(xiàn) Referen2.引言roduction該安裝確認(rèn)（IQ）針對(duì)于安裝石家莊，石藥藥業(yè)的博世設(shè)備。該現(xiàn)場(chǎng)測(cè)試主要是包括該文件的執(zhí)行及所附的測(cè)試表格，驗(yàn)證最終安裝符合已經(jīng)批準(zhǔn)的設(shè)計(jì)。This Installation Qualification (IQ) addressesch equipment installe

7、d at CSPC OuyiPharmaceutical Co., Shijiazhuang, China. The execution of thisand its attachedtests forms the field check which verifies the final installation against the approved design.3. 范圍 Scope本文件包含了 IQ 計(jì)劃以及相關(guān)必要的和文檔，以證明博世RRU 2033，721634已正確安裝。721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Pa

8、ckaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaNo.標(biāo)題Title1SOP-AG-18.007c: 驗(yàn)證計(jì)劃和的準(zhǔn)備SOP-AG-18.007c: Preparation of qualification plan & report2訂單確認(rèn)Order confirmation3SOP-AG-08.008c: 過(guò)程重要非模具的選擇SOP-AG-08. 008c: Selection of pros critical non format system components4SOP-AG

9、-23.005c: 驗(yàn)證文檔書(shū)寫(xiě)SOP-AG-23.005c: Hand-writtenation for qualification5SOP-AG-06.011c: 驗(yàn)證偏差程序SOP-AG-06.011c: Qualification deviation procedure6SOP-AG-24.004c: 變更控制程序SOP-AG-24.004c: Procedure for change control7SOP-AG-12.007c: 公共系統(tǒng)檢查SOP-AG-12.007c: Verification of Utilities8SOP-AG-09.009c: 檢查直接影響產(chǎn)品質(zhì)量的工藝

10、關(guān)鍵SOP-AG-09.009c: Verification of pros critical Components with direct impact to the Product Quality9SOP-AG-03.001e: 檢查文件SOP-AG-03.001e: Check ofs10安裝確認(rèn)IQ reportQD | IQ | IQ Plan4/9Thiscontains the IQ Plan and referennesary to collect and record the evidencet shows thech RRU 2033, 721634 has been co

11、rrectly installed.IQ 的在執(zhí)行之后在文檔10中批準(zhǔn)。The test results of the IQ will be approved after execution with 10.4. 測(cè)試方法 Test philosophy以下章節(jié)總體上描述了 IQ 的測(cè)試方法。The following chapter describes in general the test philosophy for this IQ.4.1測(cè)試途徑 Test approachIQ 的目的是收集文檔證明博世設(shè)備是根據(jù)制造商要求和的設(shè)計(jì)文檔來(lái)安裝的。The objective of this

12、 IQ is to gather andevidencet verifiest thech equip-s.ment is installed according to the manufacturers requirements and updated designIQ 計(jì)劃是根據(jù)文件1和文件2中議定的供貨范圍起草的，并符合當(dāng)前 GMP 和 cGMP 的要求。在執(zhí)行代表批準(zhǔn)。在測(cè)試并且關(guān)閉所有不符合項(xiàng)之后，IQ 測(cè)代表批準(zhǔn)和發(fā)布生效。之前該文件由博世和石藥藥業(yè)試由博世和石藥藥業(yè)The IQ plan has been produced according to 1 and the agree

13、d scope of supply in 2, which is based on current GMP and cGMP requirements. It will be approved prior execution bychanPC Ouyi Pharmaceutical Co.,represenives. After testing and closing of the nonconformanthe IQ report will be ied and approved bych anPC OuyiPharmaceutical Co.,represenives.現(xiàn)場(chǎng)安裝完成后，IQ

14、 測(cè)試依據(jù)已達(dá)成的測(cè)試博世負(fù)責(zé)測(cè)試的執(zhí)行。機(jī)器在石藥日程執(zhí)行。藥業(yè)ch is responsible for the test execution. The IQ tests will be performed after completion ofthe equipmen schedule.CSPC Ouyi Pharmaceutical Co.,premises according to the agreed testing每項(xiàng)測(cè)試的所有信息都將作為測(cè)試表格的附件。重新測(cè)試的測(cè)試文件也作為該測(cè)試的附件。All information for an individual test will

15、be attached the corresponding test sheets. Test repeti-tionation will be attached as well.根據(jù)文件3 選擇過(guò)程重要，其確認(rèn)包含在 IQ 中。Pros critical components, whose verification is withhe scope of the IQ, shall be chosenaccording to 3.用于測(cè)試執(zhí)行的圖紙、示意圖以及數(shù)據(jù)表等，作為測(cè)試表的附件并注上對(duì)應(yīng)的測(cè)試。The drawings, sketches, datasheets etc. which

16、are used for test execution will be added to theindividual test sheets and annoed with the test number.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 附錄 2）。The agreed acceptance criteria for each test are defined Appendix 附錄 2).he test scope (see chapter 5 &721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch P

17、ackaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan5/94.2測(cè)試結(jié)構(gòu) Test structure本文件中的測(cè)試結(jié)構(gòu)如下：The testshishave the following structure:測(cè)試項(xiàng)目 Title of test測(cè)試Test number測(cè)試執(zhí)行次數(shù) Test run no.測(cè)試目的Test objective測(cè)試前提Test prerequisites測(cè)試程序Test procedure接受標(biāo)準(zhǔn)Acceptance cri

18、teria所需數(shù)據(jù)（如適用）Dao be recorded (if applicable)測(cè)試后續(xù)措施（如適用）t test actions (if applicable)Test result(s)備注Comments chapter最終測(cè)試結(jié)論Final test assessment4.3測(cè)試程序 Test procedure執(zhí)行每項(xiàng)測(cè)試的程序在測(cè)試范圍表中定義（見(jiàn)第五章和Appendix 附錄 2）。The procedure for executing each Appendix 附錄 2).definedhe test scopetable (see chapter 5/4.4測(cè)試

19、前提 Test prerequisites如果適用，每項(xiàng)測(cè)試的前提都列在測(cè)試單中。If applicable, the prerequisites of each test are listedhe test sheet.4.5所需數(shù)據(jù) Dao be recorded需要作為文件證明保留的測(cè)試數(shù)據(jù)在相關(guān)測(cè)試程序中已描述。 A specification of data which should be retained as vant test procedure.ed evidence is givenhe rele-721634 I 721634_RRU 2.doc I Rev. 1.0 I

20、 en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan6/94.6測(cè)試后續(xù)措施t test actions在測(cè)試執(zhí)行之后需要考慮或采取的可能措施已在相關(guān)測(cè)試程序中做出定義。In case actions need to considered or taken after test execution they are defined test procedure.he relevant4.7Test results在測(cè)試執(zhí)行期間

21、，每個(gè)否符合。必須與期望結(jié)果相比較，必須針對(duì)該測(cè)試的每項(xiàng)接受標(biāo)準(zhǔn)判定是During test execution single test results have to be compared with the expected results, and anassessmens to be made for each acceptance criteria separay whether the result comps(yes) or not (no).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)， “如果其中一項(xiàng)或多項(xiàng)接受標(biāo)準(zhǔn)不能滿足，則判定測(cè)試失敗。“符合”一欄填寫(xiě)“是”（測(cè)試通過(guò)）

22、。符合”一欄填寫(xiě)“否”。A final assessment shall close a test. “Results comply: Yes” (Passed) shall be used if all accep- tance criteria have been met. In case one or more acceptance criteria can not be met the 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)論也需在測(cè)試范圍內(nèi)（見(jiàn)第五章/Appendix 附錄 2）。T

23、he final assessment of a test (or re-test) shall then also be recorded 5 / Appendix 附錄 2).est scope (see chapter4.8文件書(shū)寫(xiě)和備注 Handwritten entries and comments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)文件都需要簽名和日期。Data entries, comments, corrections and sign

24、atures by hand onto the prepared test sheet shallbe performed in accordance with 4. Data is to be enteredo theas theenteringexecuted. Any correction to handwritten data should normally be made by thethe data. Each page used for executing the qualification is to be signed and dated.由測(cè)量?jī)x器到儀的測(cè)試數(shù)據(jù)，應(yīng)該被打印

25、，并添加到測(cè)試表格中，由簽字確認(rèn)。數(shù)據(jù)的計(jì)算，應(yīng)該轉(zhuǎn)移到電腦上計(jì)算以后打印，然后添加到測(cè)試表格中。Dahat is gathered by instrumenion onto a recorder should be pred and then attached toa test data sheet provided the responsible author signs the data sheet. For calculation somedata should be transferred to computer and the calculation pr sheet.ed and

26、 then attached to a test4.9偏差處理 Deviation handling根據(jù)文件5，在執(zhí)行過(guò)程中發(fā)現(xiàn)的所有不符合次要偏差/偏差。使用Appendix 附錄 3 中的次要偏差日志/偏差表All exceptionst are discovered during execution are to be enteredo the deficiencies log /deviations sheet according to 5 using the deficiency sheet or the deviation sheet in Appendix附錄 3.721634

27、I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan7/9次要偏差/偏差表收錄在 IQ 文件夾中的次要偏差或偏差章節(jié)中。The deficiency / deviation sheets are collected IQ folder.he IQ deficiency or IQ deviation chapter of the4.10變更控制 Change con

28、trol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 附錄 4中的表格執(zhí)行變更控制。During the IQ this(including testing details) and all equipment must be maainedunder strict change control according to 6 using the form in Appendix 附錄 4.所有使用的變更控制表格收錄在 IQ 文件夾中的變更控制章節(jié)中。All change control forms used are collectedhe IQ ch

29、ange control chapter of the IQ folder.4.11測(cè)試總結(jié) Test summary安裝確認(rèn)的執(zhí)行情況和完成 IQ 之后的后續(xù)工作在文件10中列出。The s 10.us of the IQ execution and the follow up actions after completion of the IQ are shown in4.12nel involvedesting測(cè)試涉及的本文件中確認(rèn)活動(dòng)涉及的所有將列在Appendix 附錄 1的表中。Allnel involvedhe qualification activities of thiswi

30、ll be listed using thetable of Appendix 附錄 1.完成的列表收錄在 IQ 文件夾中的”測(cè)試涉及章節(jié)”。nel involvedThe completed list will be heldhe esting chapter of the IQ folder.5. 測(cè)試范圍 Test scope所有IQ 測(cè)試的測(cè)試步驟和接受標(biāo)準(zhǔn)在Appendix 附錄 2的表格中列出。A list of tests to be performed including the test procedures and acceptance criteria to be use

31、dduring the IQ are listedhe table of Appendix 附錄 2.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 IQ 文件夾中的“測(cè)試范圍章節(jié)”。After test execution the completed table will also conta he test scope chapter of the IQ folder.he final result for each test and held721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging Tec

32、hnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan8/96.術(shù)語(yǔ)表 Glossary7.附錄 Appendix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, 原版文件放在安裝確認(rèn)計(jì)劃中。a copy shall be taken for manual entries andIf appendiare used during the test executiontest recording the original will always be kepthe IQ

33、Plan.721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaAppendix附錄1測(cè)試涉及的所有Identification of allnel involvedestingAppendix附錄2測(cè)試范圍Test scopeAppendix附錄3次要偏差表/偏差表Deficiency Sheet / Deviation SheetAppendix附錄4變更控制表Change cont

34、rol sheetAppendix 附錄 5.1檢查公共系統(tǒng)Check of utilitiesAppendix 附錄 5.2確認(rèn)機(jī)器關(guān)鍵Verification of pros critical Machine componentsAppendix 附錄 5.3確認(rèn)工藝流程圖Verification of the pros flow diagramAppendix 附錄 5.4檢查文件Check ofsIQ安裝確認(rèn)Installation QualificationTag-no. (BmKz-Nr.)參考指南 ISO 61346-1Reference designation accordin

35、g to ISO 61346-1-tag (EMSR-Nr.)電氣儀表和控制依據(jù)DIN 19227Electrical Instrumenion and control according to DIN 19227SOP標(biāo)準(zhǔn)操作程序Standard Operating ProcedureGMP藥品生產(chǎn)質(zhì)量管理規(guī)范Good Manufacturing Practicen.a. or n/a不適用not applicableQD | IQ | IQ Plan9/9Appendix 附錄 1: 測(cè)試涉及的所有Identification of allnel involvedesting參加驗(yàn)證測(cè)試的

36、所有在下表列出，以識(shí)別在測(cè)試表格中涉及的he qualification activities of this he relevant data sheet.。Allnel involvedwill be listedhe tablebelow and identified721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaName職位/公司ition / Company日期Date簽

37、名Signature縮寫(xiě)InitialsQD | IQ | IQ Plan1/1Appendix 附錄 2: 測(cè)試范圍 Test scope附加的文件共 3 頁(yè)。The attachedcontains 3 pages.721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan1/1Appendix 附錄 3: 次要偏差/偏差表 Deficiency she

38、et / Deviation sheet附加的文件共 2 頁(yè)。The attachedcontains 2 pages.721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan1/1Appendix 附錄 4: 變更控制表 Change control sheet附加的文件共 1 頁(yè)。The attachedcontains 1 page.721634 I

39、 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan1/1Appendix 附錄 5.1: 檢查公共系統(tǒng) Check of utilities附加的文件共 3 頁(yè)。The attachedcontains 3 pages.721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRR

40、U 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan1/1Appendix 附錄 5.2: 確認(rèn)機(jī)器關(guān)鍵Verification of pros critical Machine components附加的文件共 2 頁(yè)。The attachedcontains 2 pages.721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co.

41、, Shijiazhuang, ChinaQD | IQ | IQ Plan1/1Appendix 附錄 5.3: 確認(rèn)工藝流程圖 Verification of the pros flow diagram附加的文件共 2 頁(yè)。The attachedcontains 2 pages.721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan1/1Appen

42、dix 附錄 5.4: 檢查文件 Check ofs附加的文件共 2 頁(yè)。The attachedcontains 2 pages.721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan1/1IQ 執(zhí)行IQ ExecutionRRU 2033自動(dòng)洗瓶機(jī)Automatic Washing Machine721634石藥藥業(yè)CSPC Ouyi Pharmac

43、eutical Co.,中國(guó)，石家莊Shijiazhuang, China721634 I 721634_RRU 2.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Execution1/1在 IQ 執(zhí)行中使用的 IQ 測(cè)試列表包括測(cè)試步驟以及接受標(biāo)準(zhǔn)。在測(cè)試執(zhí)行后，每項(xiàng)測(cè)試的最終結(jié)果也包含在該表中。A list of tests to be performed including the test

44、 procedures and acceptance criteria to be used during the IQ are listedhe tablebelow. After test execution this table will also contahe final result for each test.721634 I 721634_RRU 2033_IQ_Plan_App.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhu

45、ang, China測(cè)試Test No.測(cè)試項(xiàng)目Test title測(cè)試程序 Test procedure接受標(biāo)準(zhǔn)Acceptance criteria偏差/次要偏差/Deviation/ Deficiency測(cè)試符合（是/否） Results comply (yes/no)備注Comment測(cè)試Test再測(cè)試Retest1檢查公共系統(tǒng)Check of utilitiesSOP-AG- 12.007c所有接的都必須一可識(shí)。必須與相關(guān)的供應(yīng)系統(tǒng)正確接。 All connected components must be uniquely identifiable.They have to be c

46、onnected to the relevant media supply systems properly.接和設(shè)計(jì)影響單個(gè)工藝的偏差。No deviations betn actual connection dimens and design, these might compromise the individual pros.IQ 測(cè)試范圍 IQ Test scope1/5721634 I 721634_RRU 2033_IQ_Plan_App.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi

47、Pharmaceutical Co., Shijiazhuang, China測(cè)試Test No.測(cè)試項(xiàng)目Test title測(cè)試程序 Test procedure接受標(biāo)準(zhǔn)Acceptance criteria偏差/次要偏差/Deviation/ Deficiency測(cè)試符合（是/否） Results comply (yes/no)備注Comment測(cè)試Test再測(cè)試Retest2確認(rèn)機(jī)器關(guān)鍵 Verification of pros critical Machine componentsSOP-AG- 09.009c“已設(shè)計(jì)”列表上的設(shè)計(jì)數(shù)據(jù)、名、部列表符合機(jī)器上“已安裝”機(jī)、電氣。 Com

48、pliance betn the part list (as designed) and the mechanical and electrical machine components (as built) regarding to design data, item designation (BmKz) and compo- nent labeling.3確認(rèn)工藝流程圖 Verification of the pros flow diagramSOP-AG- 09.009c“已設(shè)計(jì)”工藝流程圖與“已安裝”機(jī)器一致。所有的可。 Compliance betn the pros flow di

49、agram (as designed) and machine (as built). All components are present.所有的在管中的都以正確的次序安裝。All components in piare in-IQ 測(cè)試范圍 IQ Test scope2/5721634 I 721634_RRU 2033_IQ_Plan_App.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, China測(cè)試Test No.測(cè)試項(xiàng)目

50、Test title測(cè)試程序 Test procedure接受標(biāo)準(zhǔn)Acceptance criteria偏差/次要偏差/Deviation/ Deficiency測(cè)試符合（是/否） Results comply (yes/no)備注Comment測(cè)試Test再測(cè)試Reteststalledhe right sequence.所有的正確。All components are labeled with the correcttag.IQ 測(cè)試范圍 IQ Test scope3/5721634 I 721634_RRU 2033_IQ_Plan_App.doc I Rev. 1.0 I en |72

51、1633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, China測(cè)試Test No.測(cè)試項(xiàng)目Test title測(cè)試程序 Test procedure接受標(biāo)準(zhǔn)Acceptance criteria偏差/次要偏差/Deviation/ Deficiency測(cè)試符合（是/否） Results comply (yes/no)備注Comment測(cè)試Test再測(cè)試Retest4檢查文件Check ofsSOP-AG- 03.001e可用 Availability:在訂單中的所有文件可用,語(yǔ)言和份

52、數(shù)符合要求。Alls listed he order confirmation are available he specified languages and the spe- cified number of copies.完 Completeness:每個(gè)文件的頁(yè)數(shù)正確，章錄和附錄完。Eachhas the correct number of pages, all chapters listedhe table of contents are present, and all attaents are present.明的 Obvious failures:所有文件明的(檢查文件結(jié)構(gòu)查文

53、本詳細(xì)內(nèi))。Eachappears to be without obvious failures (this is aIQ 測(cè)試范圍 IQ Test scope4/5721634 I 721634_RRU 2033_IQ_Plan_App.doc I Rev. 1.0 I en |721633ch Packaging TechnologyRRU 2033 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, China測(cè)試Test No.測(cè)試項(xiàng)目Test title測(cè)試程序 Test procedure接受標(biāo)準(zhǔn)Acceptance criteria偏差/次

54、要偏差/Deviation/ Deficiency測(cè)試符合（是/否） Results comply (yes/no)備注Comment測(cè)試Test再測(cè)試Retestcheck of thestructure and not the textual details).IQ 測(cè)試范圍 IQ Test scope5/5721634_RRU 2033_SOP-AG-12.007ec.doc | Rev. 7.0 |ch Packaging TechnologyYes No /是 否Date / 日期Initials /簽名縮寫(xiě)Results comply /符合Results approved /批準(zhǔn)

55、Test results /Yes No /是 - 否Acceptance criteria /接受標(biāo)準(zhǔn)1.All connected components must be uniquely identifi- able.所有接的都必須可一識(shí)別。They have to be connected to the relevant media supply systems properly.必須與相關(guān)的公共供應(yīng)系統(tǒng)正確接。2.No deviations betn actual connection dimens and design, these might compromise the indi

56、vidual pros.接和設(shè)計(jì)影響單個(gè)工藝的偏差。Comments /備注Test identification /測(cè)試識(shí)別Mark with X or n.a. /標(biāo)記為X或者n.a.Test測(cè)試Retest再測(cè)試Test objective /測(cè)試目的Thisto a re t all media supply systems are uniquely identi- fiable and they have to be connected to the relevant media supply sys- tems properly.項(xiàng)測(cè)試是為了確保所有的公共設(shè)施供應(yīng)系統(tǒng)可識(shí)別，并且與

57、相應(yīng)的系統(tǒng)正確接。Moreover additional information should be gathered on the as built dimen s and compared to the design.并且測(cè)量收集仍的“已安裝”信息，并且與設(shè)計(jì)相比較。Test prerequisites /測(cè)試前提Machine type /機(jī)器號(hào):RRU 2033Machine no /機(jī)器:721634Test location /Shijiazhuang,China測(cè)試場(chǎng):中國(guó),石家莊list /文件列表:Others /其:CSPC Ouyi PharmaceuticalCo.,石

58、藥藥業(yè)Verification of utilities /確認(rèn)公共設(shè)施Page / 頁(yè)數(shù)1 / Test procedure /測(cè)試程序SOP-AG-12.007ecTest number /測(cè)試IQ 1721634_RRU 2033_SOP-AG-12.007ec.doc | Rev. 7.0 |ch Packaging TechnologyComments / 備注Date / 日期Initials /簽名縮寫(xiě)Comment by /備注CSPC Ouyi PharmaceuticalCo.,石藥藥業(yè)Verification of utilities /確認(rèn)公共設(shè)施Page / 頁(yè)數(shù)2

59、/ Test procedure /測(cè)試程序SOP-AG-12.007ecTest number /測(cè)試IQ 1Automatic Washing machine / 自動(dòng)洗瓶機(jī)721634_RRU 2033_SOP-AG-12.007ec.doc | Rev. 7.0 |ch Packaging TechnologyUtility /公共設(shè)施Dimen/Comment /備注Result /結(jié)果Date / Initials日期/ 簽名縮寫(xiě)As designed已設(shè)計(jì)As built已安裝o.k.符合Not ok. /不符合Water for injection /注TC 1 “Compre

60、ssed air instrument /設(shè)備儀表所用縮氣DN 6Compressed air pros / 工藝過(guò)程所用縮氣TC 1 “Vapour ex- haust / 的DN 110/ DN 104Drain /DN 40CSPC Ouyi PharmaceuticalCo.,石藥藥業(yè)Verification of utilities /確認(rèn)公共設(shè)施Page / 頁(yè)數(shù)3 / Test procedure /測(cè)試程序SOP-AG-12.007ecTest number /測(cè)試IQ 1721634_RRU 2033_SOP-p_machine.doc | Rev.9.0 |ch Packa