博世设备文件电子版iq-rru

1、IQ 计划IQ PlanRRU 2033自动洗瓶机Automatic Washing Machine721634石药药业CSPC Ouyi Pharmaceutical Co.,中国，石家庄Shijiazhuang, China博世批准的 IQ 计划（执行前）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职责FunctionName职位/ 公司ition / Company签名Signature日期Date起草Created byZhang ZhaomingQualification Engineer, ch PackagingTechnology(Hangzhou)Co.,.审核Reviewed byXu HuiQualification Engineer, ch PackagingTechnology(Hangzhou)Co.,.批准Approved byAdrian DanihlikDepartment head, SVC, ch PackagingTechnology(Hangzh

3、ou)Co.,.QD | IQ | IQ Plan1/9批准 IQ 计划（执行前）石药药业IQ Plan approval by CSPC Ouyi Pharmaceutical Co.,(before execution)history文档历史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职责FunctionName职位/ 公司ition / Company签名Signature日期Date批准Approved by批准Approved by批准Approved byQD | IQ | IQ Plan2/9目录 Table of Contents1.参考文献 Referen42.引言roduction43.范围 Scope44.4.14.24.34.44.54.64.74.84.94.104.114.12测试方法 Test philosophy测试途径 Test approach 测试结构 Test st

5、ructure 测试程序 Test procedure测试前提 Test prerequisites5566667777888数据 Dao be recorded所需测试后续措施t test actions Test results文件书写和备注 Handwritten entries and comments偏差处理 Deviation handling变更控制 Change control测试总结 Test summarynel involvedesting测试涉及的5.测试范围 Test scope86.术语表 Glossary97.附录 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 Plan3/91.参考文献 Referen2.引言roduction该安装确认（IQ）针对于安装石家庄，石药药业的博世设备。该现场测试主要是包括该文件的执行及所附的测试表格，验证最终安装符合已经批准的设计。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. 范围 Scope本文件包含了 IQ 计划以及相关必要的和文档，以证明博世RRU 2033，721634已正确安装。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.标题Title1SOP-AG-18.007c: 验证计划和的准备SOP-AG-18.007c: Preparation of qualification plan & report2订单确认Order confirmation3SOP-AG-08.008c: 过程重要非模具的选择SOP-AG-08. 008c: Selection of pros critical non format system components4SOP-AG

9、-23.005c: 验证文档书写SOP-AG-23.005c: Hand-writtenation for qualification5SOP-AG-06.011c: 验证偏差程序SOP-AG-06.011c: Qualification deviation procedure6SOP-AG-24.004c: 变更控制程序SOP-AG-24.004c: Procedure for change control7SOP-AG-12.007c: 公共系统检查SOP-AG-12.007c: Verification of Utilities8SOP-AG-09.009c: 检查直接影响产品质量的工艺

10、关键SOP-AG-09.009c: Verification of pros critical Components with direct impact to the Product Quality9SOP-AG-03.001e: 检查文件SOP-AG-03.001e: Check ofs10安装确认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 的在执行之后在文档10中批准。The test results of the IQ will be approved after execution with 10.4. 测试方法 Test philosophy以下章节总体上描述了 IQ 的测试方法。The following chapter describes in general the test philosophy for this IQ.4.1测试途径 Test approachIQ 的目的是收集文档证明博世设备是根据制造商要求和的设计文档来安装的。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 计划是根据文件1和文件2中议定的供货范围起草的，并符合当前 GMP 和 cGMP 的要求。在执行代表批准。在测试并且关闭所有不符合项之后，IQ 测代表批准和发布生效。之前该文件由博世和石药药业试由博世和石药药业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.现场安装完成后，IQ

14、 测试依据已达成的测试博世负责测试的执行。机器在石药日程执行。药业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每项测试的所有信息都将作为测试表格的附件。重新测试的测试文件也作为该测试的附件。All information for an individual test will

15、be attached the corresponding test sheets. Test repeti-tionation will be attached as well.根据文件3 选择过程重要，其确认包含在 IQ 中。Pros critical components, whose verification is withhe scope of the IQ, shall be chosenaccording to 3.用于测试执行的图纸、示意图以及数据表等，作为测试表的附件并注上对应的测试。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.达成一致的测试的接受标准已在测试范围内定义（见第五章和Appendix 附录 2）。The agreed acceptance criteria for each test are defined Appendix 附录 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测试结构 Test structure本文件中的测试结构如下：The testshishave the following structure:测试项目 Title of test测试Test number测试执行次数 Test run no.测试目的Test objective测试前提Test prerequisites测试程序Test procedure接受标准Acceptance cri

18、teria所需数据（如适用）Dao be recorded (if applicable)测试后续措施（如适用）t test actions (if applicable)Test result(s)备注Comments chapter最终测试结论Final test assessment4.3测试程序 Test procedure执行每项测试的程序在测试范围表中定义（见第五章和Appendix 附录 2）。The procedure for executing each Appendix 附录 2).definedhe test scopetable (see chapter 5/4.4测试

19、前提 Test prerequisites如果适用，每项测试的前提都列在测试单中。If applicable, the prerequisites of each test are listedhe test sheet.4.5所需数据 Dao be recorded需要作为文件证明保留的测试数据在相关测试程序中已描述。 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测试后续措施t test actions在测试执行之后需要考虑或采取的可能措施已在相关测试程序中做出定义。In case actions need to considered or taken after test execution they are defined test procedure.he relevant4.7Test results在测试执行期间

21、，每个否符合。必须与期望结果相比较，必须针对该测试的每项接受标准判定是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).以测试的最终判定结束测试。如果满足所有接受标准， “如果其中一项或多项接受标准不能满足，则判定测试失败。“符合”一栏填写“是”（测试通过）

22、。符合”一栏填写“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”).每项测试（或再测试）的最终结论也需在测试范围内（见第五章/Appendix 附录 2）。T

23、he final assessment of a test (or re-test) shall then also be recorded 5 / Appendix 附录 2).est scope (see chapter4.8文件书写和备注 Handwritten entries and comments测试表格中手写的数据 、备注、修改和签名应该根据文件4来操作。在测试执行完成后，将测试数据填写在测试表格中。正常情况下, 任何手写数据的修改都由填写数据的人修改。执行验证使用的每页文件都需要签名和日期。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.由测量仪器到仪的测试数据，应该被打印

25、，并添加到测试表格中，由签字确认。数据的计算，应该转移到电脑上计算以后打印，然后添加到测试表格中。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偏差处理 Deviation handling根据文件5，在执行过程中发现的所有不符合次要偏差/偏差。使用Appendix 附录 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附录 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/偏差表收录在 IQ 文件夹中的次要偏差或偏差章节中。The deficiency / deviation sheets are collected IQ folder.he IQ deficiency or IQ deviation chapter of the4.10变更控制 Change con

28、trol在安装确认过程中，文件（包括测试详细信息）和设备必须严格根据文件6，使用Appendix 附录 4中的表格执行变更控制。During the IQ this(including testing details) and all equipment must be maainedunder strict change control according to 6 using the form in Appendix 附录 4.所有使用的变更控制表格收录在 IQ 文件夹中的变更控制章节中。All change control forms used are collectedhe IQ ch

29、ange control chapter of the IQ folder.4.11测试总结 Test summary安装确认的执行情况和完成 IQ 之后的后续工作在文件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测试涉及的本文件中确认活动涉及的所有将列在Appendix 附录 1的表中。Allnel involvedhe qualification activities of thiswi

30、ll be listed using thetable of Appendix 附录 1.完成的列表收录在 IQ 文件夹中的”测试涉及章节”。nel involvedThe completed list will be heldhe esting chapter of the IQ folder.5. 测试范围 Test scope所有IQ 测试的测试步骤和接受标准在Appendix 附录 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 附录 2.在测试执行完成之后， 每项测试的最终结果也包括在该表格内，收录在 IQ 文件夹中的“测试范围章节”。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.术语表 Glossary7.附录 Appendix如果在测试执行过程中需要使用附录中的测试表格,需要复印一份, 原版文件放在安装确认计划中。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附录1测试涉及的所有Identification of allnel involvedestingAppendix附录2测试范围Test scopeAppendix附录3次要偏差表/偏差表Deficiency Sheet / Deviation SheetAppendix附录4变更控制表Change cont

34、rol sheetAppendix 附录 5.1检查公共系统Check of utilitiesAppendix 附录 5.2确认机器关键Verification of pros critical Machine componentsAppendix 附录 5.3确认工艺流程图Verification of the pros flow diagramAppendix 附录 5.4检查文件Check ofsIQ安装确认Installation QualificationTag-no. (BmKz-Nr.)参考指南 ISO 61346-1Reference designation accordin

35、g to ISO 61346-1-tag (EMSR-Nr.)电气仪表和控制依据DIN 19227Electrical Instrumenion and control according to DIN 19227SOP标准操作程序Standard Operating ProcedureGMP药品生产质量管理规范Good Manufacturing Practicen.a. or n/a不适用not applicableQD | IQ | IQ Plan9/9Appendix 附录 1: 测试涉及的所有Identification of allnel involvedesting参加验证测试的

36、所有在下表列出，以识别在测试表格中涉及的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职位/公司ition / Company日期Date签

37、名Signature缩写InitialsQD | IQ | IQ Plan1/1Appendix 附录 2: 测试范围 Test scope附加的文件共 3 页。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 附录 3: 次要偏差/偏差表 Deficiency she

38、et / Deviation sheet附加的文件共 2 页。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 附录 4: 变更控制表 Change control sheet附加的文件共 1 页。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 附录 5.1: 检查公共系统 Check of utilities附加的文件共 3 页。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 附录 5.2: 确认机器关键Verification of pros critical Machine components附加的文件共 2 页。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 附录 5.3: 确认工艺流程图 Verification of the pros flow diagram附加的文件共 2 页。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 附录 5.4: 检查文件 Check ofs附加的文件共 2 页。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 执行IQ ExecutionRRU 2033自动洗瓶机Automatic Washing Machine721634石药药业CSPC Ouyi Pharmac

43、eutical Co.,中国，石家庄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 执行中使用的 IQ 测试列表包括测试步骤以及接受标准。在测试执行后，每项测试的最终结果也包含在该表中。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测试Test No.测试项目Test title测试程序 Test procedure接受标准Acceptance criteria偏差/次要偏差/Deviation/ Deficiency测试符合（是/否） Results comply (yes/no)备注Comment测试Test再测试Retest1检查公共系统Check of utilitiesSOP-AG- 12.007c所有接的都必须一可识。必须与相关的供应系统正确接。 All connected components must be uniquely identifiable.They have to be c

46、onnected to the relevant media supply systems properly.接和设计影响单个工艺的偏差。No deviations betn actual connection dimens and design, these might compromise the individual pros.IQ 测试范围 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测试Test No.测试项目Test title测试程序 Test procedure接受标准Acceptance criteria偏差/次要偏差/Deviation/ Deficiency测试符合（是/否） Results comply (yes/no)备注Comment测试Test再测试Retest2确认机器关键 Verification of pros critical Machine componentsSOP-AG- 09.009c“已设计”列表上的设计数据、名、部列表符合机器上“已安装”机、电气。 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确认工艺流程图 Verification of the pros flow diagramSOP-AG- 09.009c“已设计”工艺流程图与“已安装”机器一致。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确的次序安装。All components in piare in-IQ 测试范围 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测试Test No.测试项目

50、Test title测试程序 Test procedure接受标准Acceptance criteria偏差/次要偏差/Deviation/ Deficiency测试符合（是/否） Results comply (yes/no)备注Comment测试Test再测试Reteststalledhe right sequence.所有的正确。All components are labeled with the correcttag.IQ 测试范围 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测试Test No.测试项目Test title测试程序 Test procedure接受标准Acceptance criteria偏差/次要偏差/Deviation/ Deficiency测试符合（是/否） Results comply (yes/no)备注Comment测试Test再测试Retest4检查文件Check ofsSOP-AG- 03.001e可用 Availability:在订单中的所有文件可用,语言和份

52、数符合要求。Alls listed he order confirmation are available he specified languages and the spe- cified number of copies.完 Completeness:每个文件的页数正确，章录和附录完。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(检查文件结构查文

53、本详细内)。Eachappears to be without obvious failures (this is aIQ 测试范围 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测试Test No.测试项目Test title测试程序 Test procedure接受标准Acceptance criteria偏差/次

54、要偏差/Deviation/ Deficiency测试符合（是/否） Results comply (yes/no)备注Comment测试Test再测试Retestcheck of thestructure and not the textual details).IQ 测试范围 IQ Test scope5/5721634_RRU 2033_SOP-AG-12.007ec.doc | Rev. 7.0 |ch Packaging TechnologyYes No /是 否Date / 日期Initials /签名缩写Results comply /符合Results approved /批准

55、Test results /Yes No /是 - 否Acceptance criteria /接受标准1.All connected components must be uniquely identifi- able.所有接的都必须可一识别。They have to be connected to the relevant media supply systems properly.必须与相关的公共供应系统正确接。2.No deviations betn actual connection dimens and design, these might compromise the indi

56、vidual pros.接和设计影响单个工艺的偏差。Comments /备注Test identification /测试识别Mark with X or n.a. /标记为X或者n.a.Test测试Retest再测试Test objective /测试目的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.项测试是为了确保所有的公共设施供应系统可识别，并且与

57、相应的系统正确接。Moreover additional information should be gathered on the as built dimen s and compared to the design.并且测量收集仍的“已安装”信息，并且与设计相比较。Test prerequisites /测试前提Machine type /机器号:RRU 2033Machine no /机器:721634Test location /Shijiazhuang,China测试场:中国,石家庄list /文件列表:Others /其:CSPC Ouyi PharmaceuticalCo.,石

58、药药业Verification of utilities /确认公共设施Page / 页数1 / Test procedure /测试程序SOP-AG-12.007ecTest number /测试IQ 1721634_RRU 2033_SOP-AG-12.007ec.doc | Rev. 7.0 |ch Packaging TechnologyComments / 备注Date / 日期Initials /签名缩写Comment by /备注CSPC Ouyi PharmaceuticalCo.,石药药业Verification of utilities /确认公共设施Page / 页数2

59、/ Test procedure /测试程序SOP-AG-12.007ecTest number /测试IQ 1Automatic Washing machine / 自动洗瓶机721634_RRU 2033_SOP-AG-12.007ec.doc | Rev. 7.0 |ch Packaging TechnologyUtility /公共设施Dimen/Comment /备注Result /结果Date / Initials日期/ 签名缩写As designed已设计As built已安装o.k.符合Not ok. /不符合Water for injection /注TC 1 “Compre

60、ssed air instrument /设备仪表所用缩气DN 6Compressed air pros / 工艺过程所用缩气TC 1 “Vapour ex- haust / 的DN 110/ DN 104Drain /DN 40CSPC Ouyi PharmaceuticalCo.,石药药业Verification of utilities /确认公共设施Page / 页数3 / Test procedure /测试程序SOP-AG-12.007ecTest number /测试IQ 1721634_RRU 2033_SOP-p_machine.doc | Rev.9.0 |ch Packa