称量罩PQ验证方案

1、Dispensing Booth Performance Qualification Protocol称量罩性能确认方案xxxx Pharmaceutical Co., Ltd.xxxx制药有限公司2013年11月Protocol Approval/方案批准:部门、职务Department, Title姓名Name签名 Signature日期Date编制人Author验证管理员Validation Administrator审核人Reviewed质量中心副总监（验证）Associate Quality Director（Validation）工程中心负责人Project Center Dire

2、ctor生产中心负责人Production Center Director质量中心负责人Quality Center Director质量保证部主管QA Supervisor批准人Approved质量保证部经理QA Manager目录Index1.介绍Introduction42.目的Purpose43.范围Scope54.职责Responsibilities55.缩略语Abbreviations66.法规和指南Regulations and Guidelines77.参考文件References88.系统/设备描述System/Equipment Description99.文件管理规范Do

3、cumentation Control Procedure910.测试项目列表Test List1111.性能确认测试Installation Qualification Test1112.验证事件处理Validation Events Handling2213.性能确认报告Installation Qualification Report2214.附件清单Attachment List2415.支持性附录清单Support appendix list2416.附件 Attachment261. 介绍Introduction2. 目的Purpose本性能确认方案的目的是提供文件证据证明称量罩能

4、基于批准的工艺方法和产品标准，进行有效的重复的运行。The purpose of this PQ is to provide documented evidence that Dispensing Booth can perform effectively and reproducibly, based on the approved process method and product specification.性能测试应在真实生产条件或模拟生产条件下进行，应收集确认数据并记录在附件的测试报告上。性能确认是正式测试的最后步骤，以及确认需求矩阵中识别为进行性能确认测试的系统正式运行前正确性能

5、的文件证据。当最终性能确认报告批准后，系统可用于正常生产操作或用于工艺验证。Performance test shall be performed under real production condition or simulated production condition, and verification data shall be collected and recorded in attached test report. PQ is the last step of formal test and providing documented evidence for system

6、for which PQ is required in qualification requirement matrix with correct performance before formal operation. When the final PQ report is approved, this system can be used for Normal production operation or process validation.3. 范围Scope本性能确认是确认在正常或模拟正常生产的情况下，该称量罩的性能能够满足取样间正常工作的需求。The scope of this

7、PQ is to verify that the Dispensing Booth can be used and meet the requirements of testing process under Normal or simulated similar situation.4. 职责Responsibilities4.1验证委员会Validation committee4.1.1审核方案；Review the protocol4.1.2组织方案执行；Organize to execute the protocol4.1.3验证期间监控、追踪和收集所有数据；Monitoring, t

8、racking, and data collecting during validation4.1.4依据验证原则确保验证工作符合行业和法规要求。Based on the principles of validation to ensure that validation is in accordance with industry and regulatory requirements4.2设备与动力部Equipment and Utility department4.2.1建立设备档案；Establish equipment document4.2.2编写设备维护保养规程（SOP）Draf

9、t equipment maintenance procedures(SOP)4.3生产中心Production center4.3.1负责做好验证的各项配合工作。Responsible for arrangement the coordinate work4.4质量保证部；Quality assurance department4.3.3负责做好验证的各项配合工作。Responsible for arrangement the coordinate work4.4质量中心Quality center4.4.1撰写、审核方案；Draft and review the protocol4.4.2

10、编写设备操作规程和使用清洁规程；Draft standard operation procedure and cleaning procedure4.5质量中心Quality center4.5.1审核方案；Review the protocol4.5.2对验证全过程实施监控；Monitoring the whole process of validation4.5.3建立验证档案。Establish validation document5. 缩略语Abbreviations在下面的表格中规定了本方案中使用的缩略语。The abbreviations which will be used i

11、n this protocol are listed in the following form.缩略语ABB定义DefinitionCCA部件关键性评估Component Critical AssessmentCFDA国家食品药品监督管理总局China Food and Drug AdministrationDQ设计确认Design QualificationGMP药品生产质量管理规范Good Manufacturing PracticeID标识IdentificationIQ安装确认Installation QualificationNA不适用Not ApplicableOQ运行确认Ope

12、rational QuadrisectionPQ性能确认Performance QualificationSOP标准操作规程Standard Operational ProcedureURS用户需求说明User Requirement SpecificationSIA系统影响性评估System Influence AssessmentSATSite Acceptance Testing现场验收测试6. 法规和指南Regulations and GuidelinesThe following regulations and guidelines are referenced when compi

13、ling this protocol.为编写本方案，参考了以下法规和指南：6.1 Regulation 法规 China Food and Drug Administration (CFDA), China, Good Manufacturing Practice (2010 Revision), March, 2011,国家食品药品监督管理局（SFDA），中国，药品生产质量管理规范（2010年修订），2011 年03月。 EudraLex Volume 4, Good manufacturing practice (GMP) Guidelines, Annex 15: Qualificati

14、on and Validation , September 2001.欧盟药事法规第四卷药品生产质量管理规范，附录15 验证与确认，2001年9月。 EudraLex Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, November, 2008.EudraLex第四卷欧盟药品生产质量管理规范指南医药产品人用及兽用，2008年11月。6.2 Guidance 指南 ISPE Baseline Guide, Volume 5-Commissi

15、oning and Qualification, First Edition 2001.ISPE指南第5卷“调试和确认”2001年第一版。 Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, “Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-sterile Process Validation, Cleaning Validation”, Jul

16、y 2004, 药品监管公约，药品监管合作计划，“有关验证主计划、安装和运行确认、非无菌工艺验证、清洁验证的建议”，2004年7月。 WHO Guide to Good Manufacturing Practice (GMP) requirements, Part 2, Validation, 1997 .WHO 关于GMP要求的指南，第二部分：验证，1997年。 ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities, Volume 4: Water and Steam Systems, 2011 the

17、 second edition .（ISPE）新建和改造的工厂医药工程指南，第4卷-水和蒸汽系统，2011年第二版。 Good Automated Manufacturing Practice 5 (GAMP5), 2008 .GAMP5 良好自动化生产实践指南，2008年第5版。7. 参考文件References为编写本方案，参考了以下文件：For draft this protocol refer to following SOPs文件名称文件编号版本变更控制规程Change control procedureSOP-0501-70-00102偏差处理规程Deviation mannagm

18、ent procedureSOP-0501-70-00202人员培训管理规程Personal training procedureSOP-0901-00-00302验证主计划Validation master protocolVMP-0501-2013-01028. 系统/设备描述System/Equipment Description9. 文件管理规范Documentation Control Procedure9.1记录用笔：Recording pens 使用蓝色或黑色签字笔记录。Blue or black sign pens shall be used for recording. 9.

19、2 签名Signatures： 被授权的人员才能签署文件。Only authorized person sign on this document. 应签全名，除非文件另有规定。Unless otherwise specified, the full name shall be used as the signature. 签名应始终一致。The signatures shall be consistent.9.3填写栏目Column filling： 所有栏目必须填写。All the columns shall be filled. 填写内容与上面栏目相同也应重新填写。The full te

20、xt shall be filled even if it is the same as that in the field above. 填写栏目内容，应按照实际测试情况，对测试结果使用对勾“”填写，只能选择一种测试结果填写。Fields shall be filled according to the actual test result. The test result shall be selected with “”and only one result can be selected.9.4如下For example：文件名称 Document Name是否完整可读Complete

21、 and Readable安装确认方案Installation Qualification Protocol 是Yes 否No 若有单个栏目不需要填入内容，则在空白处填写英文字母“不适用”的简写“NA.”，表示无此项内容。If there is nothing to be filled into an individual field, NA. (Abbreviation for not applicable) shall be written in this field. 若有多个栏目不需要填入内容，应用斜线划掉，斜线上方签名，下方填写“NA.”并注明日期。If there is nothi

22、ng to be filled in more than one neighboring fields, such fields shall be crossed with a diagonal line, sign the name above the line and fill in “NA” with noted date under the line.9.5 如下For example：9.6更改错误：Correction of mistakes 在错误处划线，填入正确的内容，签名并注明更改日期，确保原先信息仍清晰可识别。When any mistakes are to be corr

23、ected, the correct record shall be entered, signed and dated for correction. The original information shall be left clearly readable.如：2012年01月02日修改人签名和修改日期2012年01月01日For example: January 2, 2012, signature and date January 1, 2012,9.7记录日期：Date Recording Format 年用4位数表示，日和月用2位数表示Four digits shall be

24、used for the indication of the year, two digits for the month and another two for the date.如：2012年09月01日For example: 2012.09.019.8书面语及名称：Written Words and Names 使用规范的书面语及名称。Standard written words and names shall be used. 文件前后名称要一致。The names shall be consistent all through the document. 9.9任何检查必须在执行的

25、同时文件化。检测工作必须遵照方案要求执行。Any execution should be documented at the same time when it is been executed. Any testing activities should be carried out under this protocol.10. 测试项目列表Test List在下面的表格列出了本方案将要执行的测试。List the tests to be executed in the table below测试编号测试名称11.1先决条件确认Prerequisites Verification11.2人

26、员确认Personnel Verification11.3文件确认Document Verification11.4培训确认Training Verification11.5测试用仪器仪表确认Instrument Verification11.6性能确认Performance Verification11. 性能确认测试Performance Qualification Test11.1先决条件确认Prerequisites Verification 确认OQ报告已经完成并审批。如果存在遗留尾项，不影响PQ进行。Purpose：To verify that the OQ report have

27、 been completed and approved. If there are any punches, make sure that cannot influence the initiation of this PQ. 程序Procedures： 确认本性能确认方案已得到批准，检查实施安装确认所必须的文件已经得到确认并可用，设备安装运行确认已经成功地完成。Method：Verify that this PQ protocol has been approved, check OQ execution document has been confirmed and available,

28、 installation qualification has been completed. 可接受标准 IQ报告已经完成并审批，偏差不影响OQ进行。Acceptance Criteria：The IQ report has been completed and approved. The deficiency will not influence the initiation of this OQ. 附件：测试结果填写在附件1先决条件确认表内。Attachment: Fill the test result in attechment1 Prerequisites Verification

29、.11.2人员确认Personnel Verification 目的：确认所有执行本方案的人员以及签名。To verify that all personnel involved in this protocol has signed 办法Method： 列出所有执行本方案的人员（姓名、公司、部门和职位）。 List all person involved in this execution（name, Company, title） 执行方案人员本人在签名处使用黑色签字笔书写本人签名及日期。 Executive person need to write signature and date

30、in the blank with black sign pen 可接受标准 Acceptance Criteria: 所有执行本方案人员本人使用黑色签字笔正确书写本人签名及日期。 Executive person write signature and date in the blank 所有执行本方案的人员（姓名、签名、公司、部门、职位和日期）已记录。 The information(name, signature, company, department, title, date) of all involved person has been recorded 附件：测试结果填写在附件

31、2人员确认表内。Attachment: Fill the test result in attachment 1 Personnel Verification11.3文件确认 Document Verification 目的purpose 确认用于检查、安装、维修所需文件的完整性、可读性。 To verify all document used for Inspection, Installation, Maintenance are in completeness and available. 确认用于检查、安装、维修所需文件的存放位置。 To verify all document use

32、d for Inspection, Installation, Maintenance in location 办法 Method 在附件3文件确认中列出用于检查、安装、维修所需所有技术文件、图纸名称。 List all technical documents, and drawing name for inspection, installation, maintenance in attachment3 document verification 根据文件名称，核实文件是否完整可读。 According to the documents name, verify that the file

33、 is complete and readable 记录文件编号、版本，以及文件存放地点。 Record the documents number, version, and file location 可接受标准：所有文件都是完整的、可读的。Acceptance criteria: All documents are complete, readable 附件：测试结果填写在附件3文件确认表内，如有偏差记录在偏差报告中。 Attachment: Fill test record in attachment3 document verification, record deviation in

34、 deviation record if it occurs11.4培训确认 Training Verification 目的：确认所有参与方案实施的人员经过验证活动培训。 Purpose: to confirm that all personnel involved in the protocol execution had been trained 程序Method： 对方案实施人员进行培训，记录方案名称、方案编号、版本号，并由培训人根据人员培训管理规程对方案实施人员培训效果进行评价。 Training to personnel that involved in the protocol,

35、 record the protocol name, number, version, and by training under Personal training procedure (SOP-0901-00-003, version: 02) to perform the training and make assessment. 可接受标准：所有方案实施人员已经过培训，培训效果合格。 Acceptance criteria: all personnel have been trained, and the training effect qualified. 附件：测试结果填写在附件3

36、培训确认表内，如有偏差记录在偏差报告中。 Attachment: fill test result in attachment 3 Training Verification, record deviation in deviation record if it occurs 11.5 测试用仪器仪表确认Testing Instrument Calibration Verification 目的Purpose 确认PQ测试使用仪器仪表经过校准，且在有效期内。To verify that the testing instruments for PQ have been calibrated an

37、d within the calibration due date. 程序Procedures 在附件5测试仪器仪表校准确认中记录生物安全柜测试用仪器仪表名称、编号、型号、用途、校准证书编号、校准日期以及下次校准日期。并检查是否能够追溯到计量基准。 Record the name, No., model, use, the calibration certificate No., calibration dates, and the next calibration dates of instruments used for biological safety cabinet IQ, and

38、attach calibration certificate list in Test Report 5 Testing Instrument Calibration Verification. And check whether it can be traced back to Standards of Measurement. 复印检查过的校准证书，签上姓名和日期，附在报告中。Copy the verified calibration certificate, Sign the name and date and attach. Acceptance Criteria可接受标准 PQ测试用

39、仪器仪表均经过校准，且在有效期内。 The testing instruments for PQ have been calibrated and are within the calibration due date. 用于校准的计量标准至少应该能够追溯有效的到计量基准。 Measurement standard for calibration can be traced back to China National Standards of Measurement. 附件：测试结果填写在附件5测试仪器仪表校准确认表内，如有偏差记录在偏差报告中。 Attachment：Fill the te

40、st results in Test Report Testing Instrument Calibration Verification, and record the deviation (if any) in Deviation Report.11.6性能确认测试Performance Verification Test 目的 Purpose确认称量罩的性能满足微生物检测要求。To verify the performance of the Dispensing Booth satisfy the requirements for micro biological test.由于本设备为

41、开放式非无菌操作设备，本方案静态测试遵循中国 cGMP A级环境标准，动态测试遵循中国 cGMP B级动态标准。、Biologic Safety Cabinet is anopen-endednon-aseptic equipment，at rest test is conformed to standard of China cGMP Class A, and operational test is conformed to standard of China cGMP Class B operational. 程序 ProceduresA 沉降菌静态测试 At rest test of c

42、olony forming unit 确认层流正常运转。Verify the laminar flow running normally 按照操作规程对设备内表面及操作台进行清洁及消毒Clean and disinfect the inner surface and operating table as the procedure request before the test. 在摆放平皿之前运行设备至少30分钟。Run the equipment for at least 30 min before distribute Petri-dishs. 按照示意图5点分布法摆放平皿，每个位置摆放

43、3个平皿。Place the Petri-dishs in 5 locations as the drawing below, 3 dishes should be placed on each position. 平皿的暴露时间为30分钟，期间无人员在此区域活动。The exposure time is 30 min，no operational activities is carried out in the mean time. 收集平皿，在37下培养48小时，用2个空白培养基做阴性对照，观察并判定培养结果。 Collect the dishes，cultivate under 37 f

44、or 48h，use 2 empty dishes for negative comparetion. 重复三次实验。 Test 3times for reproducibility.B沉降菌动态测试 Operational test of colony forming unit 确认层流正常运转。Verify the laminar flow running normally. 按照操作规程对设备内表面及操作台进行清洁及消毒Clean and disinfect the inner surface and operating table as the procedure request be

45、fore the test. 在摆放平皿之前运行设备至少30分钟。Run the equipment for at least 30 min before distribute Petri-dishs. 按照示意图5点分布法摆放平皿，每个位置摆放3个平皿。Place the Petri-dishs in 5 locations as the drawing below, 3 dishes should be placed on each position. 平皿的暴露时间为240分钟，操作人员在此期间进行正常检验操作。The exposure time is 240 min，normal op

46、erational activities should be carried out in the mean time. 收集平皿，在37下培养48小时，用2个空白培养基做阴性对照，观察并判定培养结果。 Collect the dishes，cultivate under 37 for 48h，use 2 empty dishes for nagtive comparetion. 重复三次实验。 Test 3times for reproducibility.Layout of distribution for CFU沉降菌布点位置示意图C尘埃粒子静态测试 airborne particle

47、test 确认层流正常运转。Verify the laminar flow running normally. 按照操作规程对设备内表面及操作台进行清洁及消毒Clean and disinfect the inner surface and operating table as the procedure request before the test. 在测试之前运行设备至少30分钟。Run the equipment for at least 30 min before the test.测试前，开启悬浮粒子计数器进行自净；Start the airborne particle count

48、er to self-recovery before measurement;放置取样口，开始测试；Position the probe, and then start the measurement;动态和静态各测试分别每个点采样三次，每次采样1立方米；Take 3 samples per point and sampling the volume of 1m3separately for both at rest and operational test;填写悬浮粒子记录表格，测试下个点。Fill the particle count form, and move to next poin

49、t.将悬浮粒子计数器的打印记录和隧道的运行记录附在附录后面。Attach the printout of airborne particle counter and running records to Attachment. Treatment of results结果处理当取样点数小于或等于9时，要求计算95%置信上限值（UCL）。95%置信上限可以手工计算或由粒子计数器计算。When the number of sample points is lower or equal to 9, computing the 95% Upper Confidence limit (UCL) is r

50、equired. The 95% UCL can be computed manually or by particle counter.where公式中:- M是各点平均值的算术平均值M is the overall mean of the average- s是平均值的标准偏差s is the standard deviation of the average- N是取样点数N is number of sampling points- t0.95是t分布值t0.95 is the value of Students distributionNumber of sampling point

51、s取样点数234567-9t0.956.32.92.42.12.01.9下表标出取样点Describe the sampling points in the form.悬浮粒子布点图Layout drawing of airborne particleD浮游菌静态测试 Floating Bacteria Sampler test at rest 确认层流正常运转。Verify the laminar flow running normally. 按照操作规程对设备内表面及操作台进行清洁及消毒Clean and disinfect the inner surface and operating

52、table as the procedure request before the test. 在测试之前运行设备至少30分钟。Run the equipment for at least 30 min before the test. 按照示意图使用浮游菌采样器进行采样。Sample with a Floating Bacteria Sampleras the layout described. 用浮游菌采样器采样，采样量为1立方米，期间无人员在此区域活动。The volume of sampling is 1m3 ，no operational activitie is carried o

53、ut in the mean time. 收集平皿，在37下培养48小时，用2个空白培养基做阴性对照，观察并判定培养结果。 Collect the dishes，cultivate under 37 for 48h，use 2 empty dishes for nagtive comparetion. 重复三次实验。 Test 3times for reproducibility.E浮游菌动态测试 Floating Bacteria Sampler test operational 确认层流正常运转。Verify the laminar flow running normally. 按照操作规

54、程对设备内表面及操作台进行清洁及消毒Clean and disinfect the inner surface and operating table as the procedure request before the test. 在测试之前运行设备至少30分钟。Run the equipment for at least 30 min before the test. 按照示意图使用浮游菌采样器进行采样。Sample with a Floating Bacteria Sampleras the layout described. 用浮游菌采样器采样，采样量为1立方米，期间人员在此区域正常

55、活动。The volume of sampling isr 1m3 ，normal operational activitie should be carried out in the mean time. 收集平皿，在37下培养48小时，用2个空白培养基做阴性对照，观察并判定培养结果。 Collect the dishes，cultivate under 37 for 48h，use 2 empty dishes for nagtive comparetion. 重复三次实验。 Test 3times for reproducibility. 浮游菌布点图Layout of Floating Bacteria Sampler test 可接受标准 Acceptance Criteria 区域的静态悬浮粒子数符合中国GMP C级区要求。The at rest airborne particle count meet with the requirements of Chinese GMP Class C. 0.5 m粒子数：352000