博世设备文件电子版iq-flc

1、IQ 计划IQ PlanFLC 3060西林瓶灌装机illing and Closing Machine721636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)721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, C

2、hina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(Hang

3、zhou)Co.,.FQD | 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721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, China1.026.Aug.2013Create from template.Zhang Z

4、haoming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 Scope14.12测试方法 Test philosophy测试途径 Test approach 测试结构 Test

5、 structure 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 Appendix9721636 I 721

6、636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 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 insta

7、lled 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FLC 3060，721636已正确安装。721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch

8、 Packaging TechnologyFLC 3060 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

9、-AG-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

10、的工艺关键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 FLC 3060, 721636 has been

11、 correctly 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 t

12、his 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 ag

13、reed 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

14、，IQ 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 wi

15、ll 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. whi

16、ch 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 &721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633c

17、h Packaging TechnologyFLC 3060 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

18、criteria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.

19、4测试前提 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-721636 I 721636_FLC 3.doc I Rev. 1.

20、0 I en |721633ch Packaging TechnologyFLC 3060 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

21、行期间，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

22、通过）。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

23、）。The 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 s

24、ignatures 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

25、被打印，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

26、and 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 3.7216

27、36 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 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

28、control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

29、 change 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 thi

30、swill 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

31、usedduring 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 held721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging

32、TechnologyFLC 3060 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

33、IQ Plan.721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 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 c

34、ontrol 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 accor

35、ding 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

36、测试的所有在下表列出，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 identified721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaName职位/公司ition / Company日期Da

37、te签名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.721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan1/1Appendix 附录 3: 次要偏差/偏差表 Deficiency

38、sheet / Deviation sheet附加的文件共 2 页。The attachedcontains 2 pages.721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 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.72163

39、6 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 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.721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging Technolog

40、yFLC 3060 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.721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 I CSPC Ouyi Pharmaceutical

41、Co., 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.721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan1/1Ap

42、pendix 附录 5.4: 检查文件 Check ofs附加的文件共 2 页。The attachedcontains 2 pages.721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | IQ | IQ Plan1/1IQ 执行IQ ExecutionFLC 3060西林瓶灌装机illing and Closing Machine721636石药药业CSPC Ouyi Ph

43、armaceutical Co.,中国，石家庄Shijiazhuang, China721636 I 721636_FLC 3.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaFQD | 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

44、 test procedures and acceptance criteria to be used during the IQ are listedhe tabelow. After testexecution this table will also contahe final result for each test.721636 I 721636_FLC 3060_IQ_Plan_App.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 I CSPC Ouyi Pharmaceutical Co., Shijiazh

45、uang, 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 re- levant media supply systems pro- perly.接和设计影响单个工艺的偏差。No deviations betn actual con- nection dimens and design, these might compromise the indivi- dual pros.IQ 测试范围 IQ Test scope1/3721636 I 721636_FLC 3060_IQ_Plan_App.doc I Rev. 1.0 I en |721633ch Packaging TechnologyFLC 3060 I CS

47、PC 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

48、、电气。Compliance 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 f

49、low diagram (as designed) and ma- chine (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- stalledhe right sequence.所有的正确。All components are labeled with the correcttag.IQ 测试范围 IQ Test scope2/3721636 I 721636_FLC 3060_IQ_Plan_App.doc I Rev. 1.0 I en |721633ch Packagi

50、ng TechnologyFLC 3060 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,语言和份数符合要求。Alls lis

51、tedhe order confirmation are availablehe spe- cified languages and the specified number of copies.完 Completeness:每个文件的页数正确，章录和附录完。Eachhas the correct num- ber of pages, all chapters listed in the table of contents are present, and all attaents are present.明的 Obvious failures:所有文件明的(检查文件结构查文本详细内)。Eac

52、happears to be with- out obvious failures (this is a check of thestructure and not the textual details).IQ 测试范围 IQ Test scope3/3721636_FLC 3060_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Test results /Yes No /是 - 否Ac

53、ceptance 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 individual pros.接和设计影响单个工艺的偏差。Com

54、ments /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，并且与相应的系统正确接。Moreover additional

55、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 /:FLC 3060Machine no / :721636Test location /Shijiazhuang,China :中国,石家庄list /文件列表:Others /其:CSPC Ouyi PharmaceuticalCo.,石药药业Verification of utilities /确认公共设

56、施Page / 页数1 / Test procedure /测试程序SOP-AG-12.007ecTest number /测试IQ 1721636_FLC 3060_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 / Test procedure /测试程序SOP-AG-12.007

57、ecTest number /测试IQ 1illing machine / 灌装机721636_FLC 3060_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 “Compressed air instrument /设备仪表所用缩气DN 6Compressed air

58、pros / 工艺过程所用缩气TC 1 “Vapour ex- haust / 的DN 110/ DN 104Drain /DN 40FCSPC 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 1721636_FLC 3060_SOP-p_machine.doc | Rev.9.0 |ch Packaging TechnologyYes / No是 /否Date / 日期Initials /签

59、名缩写Results comply /符合Results approved /批准Test results /Yes No /是 - 否Acceptance criteria /接受标准1.Compliance betn the part list (as designed) and the mechanical and electrical machine components (as built) regarding to design data, item designation (BmKz) and component labeling.“已设计”列表上的设计数据、名、部列表符合机器上

60、“已安装”机、电气。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 are,t critical components are installed correctly at the Machine. It is an as designed to as built comparison betnation and the Machine.项测试是确保机器关键正确安装。比较“已设计”文档与“已安装”机器是否一致。It is a