博世设备文件电子版oq-vrk

1、OQ 计划OQ PlanVRK 2005 B全自动轧盖机Fully Automatic CapMachine721637石药药业CSPC Ouyi Pharmaceutical Co.,国，石家庄Shijiazhuang, China博世批准的 OQ 计划（执行前）OQ-Plan approval bych (before execution)721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhu

2、ang, China职责FunctionName职位/公司ition / Company签名Signature日期Date起草Created byZhang ZhaomingQualification Engineer,ch Packaging Technology (Hangzhou) Co.,.审核Reviewed byXu HuiQualification Engineer,ch Packaging Technology (Hangzhou) Co.,.批准Approved byAdrian DanihlikDepartment head, SVC,ch Packaging Techno

3、logy (Hangzhou) Co.,.QD | OQ | OQ Plan1/8批准的 OQ 计划（执行前）石药药业OQ Plan approval by CSPC Ouyi Pharmaceutical Co.,(before execution)history文档历史721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, China1.026.Aug.2013Create from

4、template.Zhang Zhaoming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 | OQ | OQ Plan2/8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 app

5、roach 测试结构 Test structure 测试程序 Test procedure测试前提 Test prerequisites4556666667777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 scope76.术语表 Glossary87.附录 Append

6、ix8721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Plan3/81.参考文献 Referen2.引言roduction该运行确认（OQ）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。This Operational Qualification (OQ) addressesch equipment in

7、stalled at CSPC OuyiPharmaceutical Co., Shijiazhuang, China. The execution of thisand its attachedtests forms the field check.3.范围 Scope本文件包含了 OQ 计划以及相关必要的和文档，以证明博世VRK 2005 B，721637已正确运行。This evidencecontains the OQ Plan and referennesary to collect and record thet shows thech VRK 2005 B, 721637 ope

8、rates correctly.OQ 的在执行之后在文档8中批准。The test results of the OQ will be approved after execution with 8.4. 测试方法 Test philosophy以下章节总体上描述了 OQ 的测试方法。The following chapter describes in general the test philosophy for this OQ.721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 200

9、5 B 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 和 report2订单确认Order confirmation3SOP-AG-23.005c: 验证文档书写SOP-AG-23.005c: Handwrittenation for qualification4SOP-AG-06.011c: 验证偏差程序SOP-AG-06.011c: Qualification dev

10、iation procedure5SOP-AG-24.004c: 变更控制程序SOP-AG-24.004c Procedure for change control6SOP-LF-09.004c: 检查卷边质量SOP-LF-09.004c: Check / Quality of crim7SOP-AG-07.007c: 检查计数程序SOP-AG-07.007c: Check of counting pros8运行确认OQ reportQD | OQ | OQ Plan4/84.1测试途径 Test approachOQ 的目的是收集文档证明博世设备是根据预先协定的接受标准正确运行。The ob

11、jective of this OQ is to gather andevidencet verifiest thech equip-ment is operating correctly according to the agreed acceptance criteria.OQ 计划是根据文件1和文件2中议定的供货范围起草的，并符合当前的 GMP 和 cGMP 的要求。在执行之前该文件由博世和石药药业药业代表批准。在测试并且关闭所有不符合项之后，代表批准和发布生效。OQ 测试由博世和石药The OQ plan has been produced according to 1 and the

12、 agreed scope of supply in 2, which isbased on current GMP and cGMP requirements. It will be approved prior execution bychanPC Ouyi Pharmaceutical Co.,represenives. After testing and closing of the nonconformanthe OQ report will be ied and approved bych anPC OuyiPharmaceutical Co.,represenives.博世负责测

13、试的执行。OQ 测试依据已达成的测试日程执行。ch is responsibCSPC OuyiPharmaceutical Co.,premises according to the agreed testing schedule.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 的附件。All information for an individual test will be attached to the corresponding test sheets. Testrepetitionation will be attached as well.用于 OQ 测试执

14、行的任何附加文件，作为测试单的附件并注上对应的 试。Any additionalation used or collected during the Otest execution will be attachedto the individual 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 d fined Appendix 附录 2).he test scope (se

15、e chapter 5 &4.2测试结构 Test structure本文件中的测试拥有以下结构：The testshishave the following structure:测试题目 Title of test测试Test number测试运行次数 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 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 applicabl

16、e)Test result(s)721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Plan5/8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 exe

17、cuting each Appendix 附录 2).definedhe test scope table (see chapter 5/4.4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 pro

18、cedure.ed evidence is givenhe rele-4.6t test actions测试后续措施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，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 ha

19、ve 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。 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）。符合”一栏填写“否”。A final assessment shall close a test. “Results comply: Yes” (Passe

20、d) 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（见第五章和Appendix 附录 2）。The final assessment of a test (or re-test) shall then also be recorded 5 / Appe

21、ndix 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3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 signatures by hand onto the prepared test sheet shallbe performed in accordance wit

22、h 3. Data is to be enteredo theas theenteringexecuted. Any correction to handwritten data should normally be made by the the data. Each page used for executing the qualification is to be signed and dated.721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouy

23、i Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Plan6/8由测量仪器到仪的测试数据，应该被打印，并添加到测试表格上，由签字确认。数据的计算，应该被转移到电脑上计算以后打印，然后添加到测试表格上。Dahat is gathered by instrumenion onto a recorder may be pred and then attached to atest data sheet provided the responsible author signs the data sheet. For calculation s

24、ome datamay be transferred to computer and the calculation pred and then attached to a test sheet.4.9偏差处理 Deviation handling根据文件4，在执行过程中发现的所有不符合使用Appendix 附录 3 中的偏差表偏差。All exceptionst are discovered during execution are to be enteredo the deviation sheetaccording to 4 using the deviation sheet in Ap

25、pendix 附录 3.偏差表收录在 OQ 文件夹中的偏差章节中。The deviation sheets are collectedhe OQ deviation chapter of the OQ folder.4.10变更控制 Change control在运行确认过程中，文件（包括测试详细信息）和设备必须严格根据文件5，使用Appendix 附录 4中的表格执行变更控制。During the OQ this(including testing details) and all equipment must be maainedunder strict change control ac

26、cording to 5 using the form in Appendix 附录 4.所有使用的变更控制表收录在运行验证活页中的变更控制章节中。All change control forms used are collectedhe OQ change control chapter of the OQ folder.4.11测试总结 Test summary运行确认的执行情况和完成 OQ 之后的后续工作在文件8中列出。The s in 8.us of the OQ execution and the follow up actions after completion of the O

27、Q are shown4.12nel 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 thiswill 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 is heldhe esting chapter of the OQ folder.5. 测试范围 Test scope所有 OQ 测试的测试步骤和接受

28、标准在Appendix 附录 2的表格中列出。A list of tests to performed including the test procedures and acceptance criteria to be usedduring the OQ 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 OQ 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 th

29、e OQ folder.he final result for each test and held721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Plan7/86. 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 放在运行确认计划中。If appendiare used

30、 during the test execution a copy shall be taken for manual entries andtest recording - the original will always be kepthe OQ Plan.721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaAppendix附录1测试涉及的所有Identification

31、 of allnel involvedestingAppendix附录2测试范围Test scopeAppendix附录3偏差表Deviation SheetAppendix附录4变更控制表Change control sheetAppendix 附录 5.1检查校验状态Check of calibration susAppendix 附录 5.2检查和功能测试文件Check of AFT testationAppendix 附录 5.3检查轧盖质量Check / Quality of crim规格 Format：12 mlAppendix 附录 5.4检查计数程序Check of count

32、ing prosOQ运行确认Operational QualificationSOP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 | OQ | OQ Plan8/8Appendix 附录 1：测试涉及的所有Identification of allnel involvedesting参加验证测试的所有在下表中列出，以识别在测试表格中涉及的he qualification activities of this he relevant

33、data sheet.。Allnel involvedwill be listedhe tablebelow and identified721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaName职位/公司ition / Company日期Date签名Signature缩写InitialsQD | OQ | OQ Plan1/1Appendix 附录 2：测试范围 Test

34、 scope附加的文件共 3 页。The attachedcontains 3 pages.721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Plan1/1Appendix 附录 3：偏差表Deviation sheet附加的文件共 1 页。The attachedcontains 1 page.721637 I 721637_VRK 2005.d

35、oc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Plan1/1Appendix 4：变更控制表 Change control sheet附加的文件共 1 页。The attachedcontains 1 page.721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC

36、Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Plan1/1Appendix 附录 5.1：检查校验状态 Check of calibration sus附加的文件共 2 页。The attachedcontains 2 pages.721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ

37、 Plan1/1Appendix 附录 5.2：检查和功能测试文件 Check of AFT testation附加的文件共 2 页。The attachedcontains 2 pages.721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Plan1/1Appendix 附录 5.3：检查卷边质量 Check / Quality of crim附

38、加的文件共 2 页。The attachedcontains 2 pages.721637 I 721637_VRK 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Plan1/1Appendix 附录 5.4：检查计数程序 Check of counting pros附加的文件共 3 页。The attachedcontains 3 pages.721637 I 721637_VRK

39、 2005.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Plan1/1OQ 执行OQ ExecutionVRK 2005 B全自动轧盖机Fully Automatic CapMachine721637石药药业CSPC Ouyi Pharmaceutical Co.,国，石家庄Shijiazhuang, China721637 I 721637_VRK 2005.doc I Rev. 1.0

40、I en |721633ch Packaging TechnologyVRK 2005 B I CSPC Ouyi Pharmaceutical Co., Shijiazhuang, ChinaQD | OQ | OQ Execution1/1在 OQ 执行中使用的 OQ 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 performed including the test procedures and acceptance criteria to be used during the OQ are listedhe t

41、abelow. After testexecution this table will also contahe final result for each test.721637 I 721637_VRK 2005 B_OQ_Plan_App.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B 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 criteri

42、a偏差Deviation测试符合（是/否）Results comply (yes/no)备注Comment测试Test再测试Retest1检查校验状态Check of calibration susSOP-AC- 08.006c测量：测量或器的最终校验 有效。Measuring loop: The last calibration of the measuring loop or the sensor is still valid.测试仪器：使用的相关仪器在校验行 有效。Test device: The calibrations of the test deviwere valid at th

43、e time the calibration was performed.程序：校验程序必须可用并在 效期内。 Procedure: A calibration procedure must be available and valid.文档：校验结果以文件，并且有数、签名和日期。ation: The results of the calibrations are properlyed with values, signatures and dates.结果：所有结果必须在规定的公差范围 内。Results: All calibration results are withhe specifi

44、ed toleran.OQ Test Scope1/3721637 I 721637_VRK 2005 B_OQ_Plan_App.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B 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Deviation测试符合（是/否）Results comply (yes/no)备注Comment测试Te

45、st再测试Retest2检查和功能测试文件Check of AFT testationSOP-AG- 26.004c文档：和功能测试文档与完。ation:AFT testation and records are completed.执行：执行所有测试并签名。Execution:All tests are executed and signed.偏差:偏差已关闭并正确。Deviations:Deviations are closed and documen- ted correctly.OQ Test Scope2/3721637 I 721637_VRK 2005 B_OQ_Plan_App

46、.doc I Rev. 1.0 I en |721633ch Packaging TechnologyVRK 2005 B 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Deviation测试符合（是/否）Results comply (yes/no)备注Comment测试Test再测试Retest3检查卷边质量 Check / Quality of crim规格 Format：12 mlSOP-LF-

47、09.004c检查质量：卷边与盖完，并不，不接。Check of the quality:The crimhas to fit well to the vial head and shall not lean further on against the vial neck.检查状：有任何状。Check of pleats:There shall not be any pleats.检查：盖不动，Check of fixation:The cap shall not be loose.检查过程完：当品 n=100 ，99%卷边完。 Check of the complete pros: Whe

48、n n = 100 sles, 99% of them have to have a good crim.4检查计数程序 Check of counting prosSOP-AG- 07.007c最计数差范围： n 的 1% Max. fault of counting: 1% of n. n=200 vialsOQ Test Scope3/3721637_VRK 2005 B_SOP-AC-08.006ec.doc | Rev. 6.0 |ch Packaging TechnologyYes / 是No / 否Date / 日期Initials /签名缩写Results comply /符合

49、Results approved /批准Test results /Yes No /是-否Acceptance criteria /接受标准1.The last calibration of the measuring loop or the sen- sor is still valid. 测量或器的校验有效。2.The calibrations of the test deviwere valid at the time the calibration was performed.使用的相关仪器在校验行有效。3.A calibration procedure must be availab

50、le and valid.校验程序必须可用并且有效。4.The results of the calibrations are properly documen- ted with values, signatures and dates.校验结果以文件，并且有数、签名和日期。5.All calibration results are withhe specified toleran-. 所有的校准结果在规定的公差范围内。Checked list of sensors to be calibrated is attached to this/需要校准的器的检查列表也附加在文档中Number o

51、f pages / 页数: 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 ensure before the OQ startst all critical probes and pros measuring loops are correctly calibrated: 项测试是为了确保在 OQ 之前，所有重要的器以及测试已被正确的校准过。The last calibration of the measuring loop is still val

52、id.测量的最后校准依然是有效的。The last calibration of the reference equipment is still valid.相关设备的校准依然是有效的。Test prerequisites /测试前提Machine type /机器号:VRK 2005 BMachine no /机器:721637Test location /Shijiazhuang,China测试:,石家庄list /文件列表:Others /其:CSPC Ouyi Pharmaceutical Co.,/石药药业Check of calibration sus /检查校验状态Page /

53、 页数1 / Test procedure /测试程序SOP-AC-08.006cTest number /测试OQ 1721637_VRK 2005 B_SOP-AC-08.006ec.doc | Rev. 6.0 |ch Packaging TechnologyComments /备注Date / 日期Initials /签名缩写Comment by /备注CSPC Ouyi Pharmaceutical Co.,/石药药业Check of calibration sus /检查校验状态Page / 页数2 / Test procedure /测试程序SOP-AC-08.006cTest

54、number /测试OQ 1721637_VRK 2005 B_SOP-AG-07.007ec.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Acceptance criteria /接受标准1.Max. fault of count 1% of n.最计数差范围：: n 的 1%。 n= 200oules or vials.n=200 安或。Comments /备注in

55、g: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This test checks the reliability and accuracy of the container counter in production mode.项测试检测在生产下器计数器的可及确。Test prerequisites /测试前提Machine type /机器号:VRK 2005 BMachine no /机器:721637Test location /Shijiazhuan

56、g,China测试:中国,石家庄CSPC Ouyi Pharmaceutical Co.,/石药药业Check of counting pros /检查计数程序Page / 页数1 / Test procedure /测试程序SOP-AG-07.007cTest number /测试OQ 4721637_VRK 2005 B_SOP-AG-07.007ec.doc | Rev.7.0 |ch Packaging TechnologyTest results /Name of counter / 计数器名:Test 1测试 1Test 2测试 2Test 3测试 3Initials /签名缩写C

57、ounter reading /计数器数Start /End /结束Difference /差Number of containers / 器数量1122Results ofs 1 and 2 fulfill acceptance criteria /1 和 2 的结果是否满足接受标准:Yes/是/No/否Comments / 备注Date / 日期Initials /签名缩写Comment by /备注CSPC Ouyi Pharmaceutical Co.,/石药药业Check of counting pros /检查计数程序Page / 页数2 / Test procedure /测试程

58、序SOP-AG-07.007cTest number /测试OQ 4721637_VRK 2005 B_SOP-LF-09.004ec.doc | Rev. 4.0 |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Acceptance criteria /接受标准1.Check of the quality:The crimhas to fit well to the vial head and sh

59、all not lean further on against the vial neck.检查质量：卷边与盖完，并不，不接。2.Check of pleats:There shall not be any pleats.检查有任何状。3.Check of fixation:The cap shall not be loose.检查:盖不动，。4.Check of the complete pros:When n = 100 sles, 99% of them have to have a good crim.检查过程完：当品 n=100 ，99%卷边完。Comments /备注Test id

60、entification /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The quality of the crimwill be checked.检查卷边质量。Test prerequisites /测试前提Machine type /机器号:VRK 2005 BMachine no /机器:721637Test location /Shijiazhuang,China测试:中国,石家庄Format /规格:CSPC Ouyi Pharmaceutical Co.,/石药药业Check/Qual