稱量罩PQ驗證方案

1、Dispe nsing BoothPerforma nee Qualificati on Protocol稱量罩性能確認方案xxxx Pharmaceutical Co., Ltd.xxxx 制藥有限公司2013 年 11 月Protocol Approval/ 方案批準:部門、職務(wù)Departme nt. Title姓名Name簽名Sig nature日期Date編制人Author驗證管理員Validati on Admi nistrator審核人Reviewed質(zhì)量中心副總監(jiān)(驗證)Associate Quality Director(Validation )工程中心負責人Project

2、Cen ter Director生產(chǎn)中心負責人Producti on Cen terDirector質(zhì)量中心負責人Quality Cen ter Director質(zhì)量保證部主管QA Supervisor批準人Approved質(zhì)量保證部經(jīng)理QA Manager目錄In dex1.介紹 Introduction .42.目的 Purpose .43.范圍 Scope .54.職責 Responsibilities . 45.縮略語 Abbreviati ons .66.法規(guī)和指南 Regulations and Guidelines .67.參考文件 References .88.系統(tǒng) /設(shè)備描述

3、 System/Equipment Description .99.文件管理規(guī)范 Documentation Control Procedure .910. 測試項目列表 Test List . 1111. 性能確認測試 Installation Qualification Test .1012. 驗證事件處理 Validation Events Handling .2213. 性能確認報告 Installation Qualification Report .2014. 附件清單 Attachment List .2215. 支持性附錄清單 Support appendix list .22

4、16. 附件 Attachment .231.介紹 Introduction2.目的 Purpose本性能確認方案的目的是提供文件證據(jù)證明稱量罩能基于批準的工藝方法和產(chǎn)品標準，進行有 效的重復(fù)的運行。The purpose of this PQ is to provide documented evidenee that Dispensing Booth can performeffectively and reproducibly, based on the approved process method and product specificati on.性能測試應(yīng)在真實生產(chǎn)條件或模擬生

5、產(chǎn)條件下進行，應(yīng)收集確認數(shù)據(jù)并記錄在附件的測試報告 上。性能確認是正式測試的最后步驟， 以及確認需求矩陣中識別為進行性能確認測試的系統(tǒng)正 式運行前正確性能的文件證據(jù)。當最終性能確認報告批準后，系統(tǒng)可用于正常生產(chǎn)操作或用于 工藝驗證。Performa nee test shall be performed un der real product ion con diti on or simulated producti oncondition, and verification data shall be collected and recorded in attached test repor

6、t. PQ is the laststep of formal test and providi ng docume nted evide nee for system for which PQ is required inqualificati on requireme nt matrix with correct performa nee before formal operati on.Whe n the final PQ report is approved, this system can be used for Normal product ion operati on orpro

7、cess validatio n.3.范圍 Scope本性能確認是確認在正?；蚰M正常生產(chǎn)的情況下，該稱量罩的性能能夠滿足取樣間正常工作 的需求。The scope of this PQ is to verify that the Dispe nsing Booth can be used and meet the requireme ntsof test ing process un der Normal or simulated similar situati on.4.職責 Responsibilities4.1驗證委員會Validatio n committee4.1.1審核方案；Re

8、view the protocol4.1.2組織方案執(zhí)行；Orga nize to execute the protocol4.1.3驗證期間監(jiān)控、追蹤和收集所有數(shù)據(jù)；Monitoring, tracking, and data collecting during validation4.1.4依據(jù)驗證原則確保驗證工作符合行業(yè)和法規(guī)要求。Based on the principles of validation to ensure that validation is in accordanee with in dustryand regulatory requireme nts4.2設(shè)備與動

9、力部Equipme nt and Utility departme nt4.2.1建立設(shè)備檔案；Establish equipme nt docume nt4.2.2編寫設(shè)備維護保養(yǎng)規(guī)程(SOP)Draft equipme nt maintenance procedures(SOP)4.3生產(chǎn)中心Product ion cen ter4.3.1負責做好驗證的各項配合工作。Resp on sible for arran geme nt the coord in ate work4.4質(zhì)量保證部；Quality assura nee departme nt4.3.3負責做好驗證的各項配合工作。Re

10、sp on sible for arran geme nt the coord in ate work4.4質(zhì)量中心Quality cen ter4.4.1撰寫、審核方案；Draft and review the protocol4.4.2編寫設(shè)備操作規(guī)程和使用清潔規(guī)程；Draft sta ndard operati on procedure and clea ning procedure4.5質(zhì)量中心Quality cen ter4.5.1審核方案；Review the protocol4.5.2對驗證全過程實施監(jiān)控；Monitoring the whole process of valid

11、ation4.5.3建立驗證檔案Establish validati on docume nt5.縮略語 Abbreviations在下面的表格中規(guī)定了本方案中使用的縮略語。The abbreviations which will be used in this protocol are listed in the following form.縮略語ABB定義Defin iti onCCA部件關(guān)鍵性評估Comp onent Critical Assessme ntCFDA國家食品藥品監(jiān)督管理總局China Food and Drug Adm ini strati onDQ設(shè)計確認Desig

12、n Qualificati onGMP藥品生產(chǎn)質(zhì)量管理規(guī)范Good Manu facturi ng PracticeID標識Ide ntificati onIQ安裝確認Installation QualificationNA不適用Not ApplicableOQ運行確認Operati onal Quadrisecti onPQ性能確認Performa nee Qualificati onSOP標準操作規(guī)程Sta ndard Operati onal ProcedureURS用戶需求說明User Requirement SpecificationSIA系統(tǒng)影響性評估System In flue

13、nee Assessme ntSATSite Accepta nee Testi ng現(xiàn)場驗收測試6.法規(guī)和指南 Regulations and GuidelinesThe following regulations and guidelines are refereneed when compiling this protocol.為編寫本方案，參考了以下法規(guī)和指南：6.1Regulation 法規(guī)?China Food and Drug Administration (CFDA), China. Good Manufacturing Practice（2010 Revisio n）, Ma

14、rch, 2011,國家食品藥品監(jiān)督管理局（SFDA），中國，藥品生產(chǎn)質(zhì)量管理規(guī)范（2010 年修訂），2011 年 03 月。?EudraLex Volume 4, Good manufacturing practice (GMP) Guidelines, Annex 15: Qualificationand Validation , September 2001.歐盟藥事法規(guī)第四卷藥品生產(chǎn)質(zhì)量管理規(guī)范，附錄15 驗證與確認，2001 年 9 月。?EudraLex Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal

15、 Products for Human and Veteri nary Use, November, 2008.EudraLex 第四卷歐盟藥品生產(chǎn)質(zhì)量管理規(guī)范指南醫(yī)藥產(chǎn)品人用及獸用，2008 年 11 月。6.2 Guida nee 指南?ISPE Baseline Guide, Volume 5-Commissioning and Qualification, First Edition 2001. ISPE 指南第 5 卷“調(diào)試和確認” 2001 年第一版。?Pharmaceutical Inspection Convention, Pharmaceutical Inspection C

16、o-operation Scheme,“ Recomme ndati ons on Validati on Master Pla n, In stallatio n and Operatio nal Qualification,Non- sterile Process Validation, Cleaning Validation”，July 2004,藥品監(jiān)管公約，藥品監(jiān)管合作計劃，有關(guān)驗證主計劃、安裝和運行確認、非無菌工藝驗證、清潔驗證的建議”，2004 年 7 月。?WHO Guide to Good Manufacturing Practice (GMP) requirements,

17、Part 2, Validation, 1997 .WHO 關(guān)于 GMP 要求的指南，第二部分：驗證，1997 年。?ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities, Volume4: Water and Steam Systems, 2011 the seco nd editio n .(ISPE )新建和改造的工廠醫(yī)藥工程指南，第 4 卷-水和蒸汽系統(tǒng)，2011 年第二版。?Good Automated Manufacturing Practice 5 (GAMP5), 2008 .GAMP5

18、良好自動化生產(chǎn)實踐指南，2008 年第 5 版。7. 參考文件 References為編寫本方案，參考了以下文件：For draft this protocol refer to followi ng SOPs文件名稱文件編號版本變更控制規(guī)程SOP-0501-70-00102Change con trol procedure偏差處理規(guī)程Deviati on mann agme ntprocedureSOP-0501-70-00202人員培訓管理規(guī)程Pers onal trai ning procedureSOP-0901-00-00302驗證主計劃Validati on master prot

19、ocolVMP-0501-2013-01028.系統(tǒng)/設(shè)備描述 System/Equipment Description9.文件管理規(guī)范 Documentation Control Procedure9.1 記錄用筆： Record ing pens?使用藍色或黑色簽字筆記錄。Blue or black sig n pens shall be used for record ing.9.2 簽名 Sig natures :?被授權(quán)的人員才能簽署文件。Only authorized pers on sig n on this docume nt.?應(yīng)簽全名，除非文件另有規(guī)定。Uni ess ot

20、herwise specified, the full n ame shall be used as the sig nature.?簽名應(yīng)始終一致。The sig natures shall be con siste nt.9.3 填寫欄目 Column filling :?所有欄目必須填寫。All the colu mns shall be filled.?填寫內(nèi)容與上面欄目相同也應(yīng)重新填寫。The full text shall be filled even if it is the same as that in the field above.?填寫欄目內(nèi)容，應(yīng)按照實際測試情況，對測

21、試結(jié)果使用對勾“V”填寫，只能選擇一種測試結(jié)果填寫。Fields shall be filled according to the actual test result. The test result shall beselected with and only one result can be selected.9.4如下For example :文件名稱Docume nt Name是否完整可讀Complete and Readable安裝確認方案Installation Qualification Protocol功是 Yes 口否 No?若有單個欄目不需要填入內(nèi)容，則在空白處填寫英文

22、字母“不適用”的簡寫“NA. ”，表示無此項內(nèi)容。If there is nothing to be filled into an in dividual field, NA. (Abbreviati on for not applicable) shallbe written in this field.?若有多個欄目不需要填入內(nèi)容，應(yīng)用斜線劃掉，斜線上方簽名，下方填寫“ NA. ”并注明日期。If there is nothing to be filled in more than one neighboring fields, such fields shall becrossed wi

23、th a diag on al li ne, sig n the n ame above the line and fill in“ NAdate un der the line.?在錯誤處劃線，填入正確的內(nèi)容，簽名并注明更改日期，確保原先信息仍清晰可識別When any mistakes are to be corrected, the correct record shall be en tered, sig ned and dated forcorrection. The original information shall be left clearly readable.女口： 20

24、12 年 01 月 02 日修改人簽名和修改日期2012年01月01日For example: January 2, 2012, sig nature and dateJanuary 1,2012,9.7 記錄日期： Date Record ing Format?年用 4 位數(shù)表示，日和月用 2 位數(shù)表示Four digits shall be used for the in dicati on of the year, two digits for the mon th and ano ther two forwiththe date.女口： 2012 年 09 月 01 日For exam

25、ple: 2012.09.019.8 書面語及名稱： Written Words and Names?使用規(guī)范的書面語及名稱。Sta ndard writte n words and n ames shall be used.?文件前后名稱要一致。The n ames shall be con siste nt all through the docume nt.9.9 任何檢查必須在執(zhí)行的同時文件化。檢測工作必須遵照方案要求執(zhí)行。Any execution should be documented at the same time when it is been executed. Any

26、testingactivities should be carried out under this protocol.10. 測試項目列表 Test List在下面的表格列出了本方案將要執(zhí)行的測試。List the tests to be executed in the table below測試編號測試名稱11.1先決條件確認Prerequisites Verificati on11.2人員確認Personnel Verification11.3文件確認Docume nt Verificati on11.4培訓確認Trai ning Verificati on11.5測試用儀器儀表確認In

27、 strume nt Verificati on11.6性能確認Performa nee Verificati on11. 性能確認測試 Performanee Qualification Test11.1 先決條件確認 Prerequisites Verification?確認 0Q 報告已經(jīng)完成并審批。如果存在遺留尾項，不影響 PQ 進行Purpose : To verify that the OQ report have been completed and approved. If there are any punches, make sure that cannot in flue

28、 nee the in itiati on of this PQ.?程序 Procedures :?確認本性能確認方案已得到批準，檢查實施安裝確認所必須的文件已經(jīng)得到確認并可用，設(shè)備安裝運行確認已經(jīng)成功地完成。Method : Verify that this PQ protocol has been approved, check OQ execution docume nt has been con firmed and available, in stallatio n qualificati on has bee n completed.?可接受標準IQ 報告已經(jīng)完成并審批，偏差不影響

29、 OQ 進行。Acceptanee Criteria : The IQ report has been completed and approved. The deficie ncy will not influe nce the in itiati on of this OQ.? 附件：測試結(jié)果填寫在附件 1先決條件確認表內(nèi)。Attachment: Fill the test result in attechment1 Prerequisites Verification.11.2 人員確認 Personnel Verification?目的：確認所有執(zhí)行本方案的人員以及簽名。To veri

30、fy that all pers onnel invo Ived in this protocol has sig ned?辦法 Method :?列出所有執(zhí)行本方案的人員(姓名、公司、部門和職位)。? List all person invoIved in this execution (name, Company, title )?執(zhí)行方案人員本人在簽名處使用黑色簽字筆書寫本人簽名及日期。? Executive pers on n eed to write sig nature and date in the bla nk with black sig n pen?可接受標準 Accept

31、ance Criteria:?所有執(zhí)行本方案人員本人使用黑色簽字筆正確書寫本人簽名及日期。? Executive pers on write sig nature and date in the bla nk?所有執(zhí)行本方案的人員（姓名、簽名、公司、部門、職位和日期）已記錄The in formati on(n ame, sig nature, compa ny, departme nt, title, date) of all invo Ived pers onhas bee n recorded附件：測試結(jié)果填寫在附件 2人員確認表內(nèi)Attachment: Fill the test re

32、sult in attachment 1 Personnel Verification11.3 文件確認 Document Verification?目的 purpose?確認用于檢查、安裝、維修所需文件的完整性、可讀性。? To verify all document used for Inspection, Installation, Maintenance are in complete ness andavailable.?確認用于檢查、安裝、維修所需文件的存放位置。? To verify all document used for Inspection, Installation,

33、Maintenance in location?辦法 Method?在附件 3文件確認中列出用于檢查、安裝、維修所需所有技術(shù)文件、圖紙名稱? List all technical documents, and drawing name for inspection, installation, maintenance inattachme nt3 docume nt verificati on?根據(jù)文件名稱，核實文件是否完整可讀。? According to the documents name, verify that the file is complete and readable?記錄

34、文件編號、版本，以及文件存放地點。? Record the documents number, version, and file location?可接受標準：所有文件都是完整的、可讀的。Accepta nee criteria: All docume nts are complete, readable?附件：測試結(jié)果填寫在附件 3文件確認表內(nèi)，如有偏差記錄在偏差報告中。?Attachment: Fill test record in attachment3 document verification, record deviation in deviationrecord if it o

35、ccurs11.4 培訓確認 Training Verification?目的：確認所有參與方案實施的人員經(jīng)過驗證活動培訓。?Purpose: to con firm that all pers onnel invo Ived in the protocol executio n had bee n trained?程序 Method :?對方案實施人員進行培訓，記錄方案名稱、方案編號、版本號，并由培訓人根據(jù)人員培訓管理規(guī)程對方案實施人員培訓效果進行評價。?Trai ning to pers onnel that invo Ived in the protocol, record the pr

36、otocol n ame, nu mber,versi on, and by trai ning un der Pers onal trai ning procedure (SOP-0901-00-003, versi on: 02) toperform the training and make assessme nt.?可接受標準：所有方案實施人員已經(jīng)過培訓，培訓效果合格。?Acceptanee criteria: all personnel have been trained, and the training effect qualified.?附件：測試結(jié)果填寫在附件 3培訓確認表內(nèi)

37、，如有偏差記錄在偏差報告中。?Attachment: fill test result in attachment 3 Training Verification, record deviation in deviation record ifit occurs11.5 測試用儀器儀表確認 Testi ng In strume nt Calibratio n Verificati on?目的 Purpose確認 PQ 測試使用儀器儀表經(jīng)過校準，且在有效期內(nèi)。To verify that the testing instruments for PQ have been calibrated an

38、d within the calibrati on duedate.?程序 Procedures?在附件 5測試儀器儀表校準確認中記錄生物安全柜測試用儀器儀表名稱、編號、型號、用途、校準證書編號、校準日期以及下次校準日期。并檢查是否能夠追溯到 計量基準。? Record the name, No., model, use, the calibration certificate No., calibration dates, and the n extcalibrati on dates of in strume nts used for biological safety cab inet

39、IQ, and attach calibrati oncertificate list in Test Report 5 Testi ng In strume nt Calibrati on Verificatio n. And check whetherit can be traced back to Stan dards of Measureme nt.?復(fù)印檢查過的校準證書，簽上姓名和日期，附在報告中。Copy the verified calibration certificate, Sign the name and date and attach.Acceptanee Criter

40、ia 可接受標準? PQ 測試用儀器儀表均經(jīng)過校準，且在有效期內(nèi)。? The testing instruments for PQ have been calibrated and are within the calibration due date.?用于校準的計量標準至少應(yīng)該能夠追溯有效的到計量基準。? Measurement standard for calibration can be traced back to China NationalStan dards of Measureme nt.?附件：測試結(jié)果填寫在附件 5測試儀器儀表校準確認表內(nèi)，如有偏差記錄在偏差報告中。?At

41、tachment : Fill the test results in Test Report Testing Instrument Calibration Verificati on, andrecord the deviati on (if any) in Deviati on Report.11.6 性能確認測試 Performanee Verification Test?目的 Purpose確認稱量罩的性能滿足微生物檢測要求。To verify the performa nee of the Dispe nsing Booth satisfy the requireme nts for

42、 micro biologicaltest.由于本設(shè)備為開放式非無菌操作設(shè)備，本方案靜態(tài)測試遵循中國cGMP A 級環(huán)境標準,動態(tài)測試遵循中國 cGMP B 級動態(tài)標準。、Biologic Safety Cabinet is anopen-endednon-aseptic equipment，at rest test iscon formed to sta ndard of Chi na cGMP Class A, and operati onal test is con formed to sta ndardof Chi na cGMP Class B operatio nal.?程序 Pr

43、oceduresA. 沉降菌靜態(tài)測試 At rest test of colony forming unit?確認層流正常運轉(zhuǎn)。Verify the lam inar flow running no rmally?按照操作規(guī)程對設(shè)備內(nèi)表面及操作臺進行清潔及消毒Clea n and dis infect the inner surface and operati ng table as the procedure request before thetest.?在擺放平皿之前運行設(shè)備至少 30 分鐘。Run the equipment for at least 30 min before dis

44、tribute Petri-dishs.?按照示意圖 5 點分布法擺放平皿，每個位置擺放 3 個平皿。Place the Petri-dishs in 5 locations as the drawing below, 3 dishes should be placed on eachpositi on.?平皿的暴露時間為 30 分鐘，期間無人員在此區(qū)域活動。The exposure time is 30 min ，no operational activities is carried out in the mean time.?收集平皿，在 37C下培養(yǎng) 48 小時，用 2 個空白培養(yǎng)基做

45、陰性對照，觀察并判定培養(yǎng)結(jié)果Collect the dishes , cultivate under 37 C for 48h , use 2 empty dishes for negative comparetion.?重復(fù)三次實驗。? Test 3times for reproducibility.B .沉降菌動態(tài)測試 Operati onal test of colony formi ng unit?確認層流正常運轉(zhuǎn)。Verify the lam inar flow running no rmally.?按照操作規(guī)程對設(shè)備內(nèi)表面及操作臺進行清潔及消毒Clea n and dis infe

46、ct the inner surface and operati ng table as the procedure request before thetest.?在擺放平皿之前運行設(shè)備至少 30 分鐘。Run the equipment for at least 30 min before distribute Petri-dishs.?按照示意圖 5 點分布法擺放平皿，每個位置擺放 3 個平皿。Place the Petri-dishs in 5 locations as the drawing below, 3 dishes should be placed on eachpositi

47、 on.?平皿的暴露時間為 240 分鐘，操作人員在此期間進行正常檢驗操作。The exposure time is 240 min ，normal operational activities should be carried out in the meantime.?收集平皿，在 37C下培養(yǎng) 48 小時，用 2 個空白培養(yǎng)基做陰性對照，觀察并判定培養(yǎng) 結(jié)果。? Collect the dishes，cultivate under 37Cfor 48h，use 2 empty dishes for nagtive comparetio n.?重復(fù)三次實驗。? Test 3times fo

48、r reproducibility.Layout of distribution for CFU 沉降菌布點位置示意圖C .塵埃粒子靜態(tài)測試 airborne particle test?確認層流正常運轉(zhuǎn)。Verify the lam inar flow running no rmally.?按照操作規(guī)程對設(shè)備內(nèi)表面及操作臺進行清潔及消毒Clea n and dis infect the inner surface and operati ng table as the procedure request before thetest.?在測試之前運行設(shè)備至少 30 分鐘。Run the eq

49、uipme nt for at least 30 min before the test.測試前，開啟懸浮粒子計數(shù)器進行自凈；Start the airbor ne particle coun ter to self-recovery before measureme nt;放置取樣口，開始測試；Positi on the probe, and the n start the measureme nt;動態(tài)和靜態(tài)各測試分別每個點采樣三次，每次采樣1 立方米；3Take 3 samples per point and sampli ng the volume of 1m separately f

50、or both at rest andoperati onal test;填寫懸浮粒子記錄表格，測試下個點。Fill the particle count form, and move to n ext point.將懸浮粒子計數(shù)器的打印記錄和隧道的運行記錄附在附錄后面。Attach the prin tout of airbor ne particle coun ter and running records to Attachme nt.? Treatment of results 結(jié)果處理當取樣點數(shù)小于或等于 9 時，要求計算 95%置信上限值(UCL )。95%置信上限可以 手工計算或

51、由粒子計數(shù)器計算。Whe n the nu mber of sample points is lower or equal to 9, comput ing the 95%Upper Con fide nce limit (UCL) is required. The 95% UCL can be computed manu ally or byparticle coun ter.95%UCL Mt,95S/Nwhere 公式中:-M 是各點平均值的算術(shù)平均值M is the overall mean of the average-s 是平均值的標準偏差s is the sta ndard de

52、viati on of the average-N 是取樣點數(shù)N is nu mber of sampli ng poi nts-t0.95是 t 分布值to.95is the value of Student s distributionNumber of sampli ngpoi nts取樣點數(shù)234567-9t0.956.32.92.42.12.01.9F 表標出取樣點Describe the sampling points in the form.oo懸浮粒子布點圖 Layout drawing of airborne particleD .浮游菌靜態(tài)測試 Floati ng Bact

53、eria Sampler test at rest?確認層流正常運轉(zhuǎn)。Verify the lam inar flow running no rmally.?按照操作規(guī)程對設(shè)備內(nèi)表面及操作臺進行清潔及消毒Clea n and dis infect the inner surface and operati ng table as the procedure request beforethe test.?在測試之前運行設(shè)備至少 30 分鐘。Run the equipme nt for at least 30 min before the test.?按照示意圖使用浮游菌采樣器進行采樣。Samp

54、le with a Floati ng Bacteria Sampleras the layout described.?用浮游菌采樣器采樣，采樣量為 1 立方米，期間無人員在此區(qū)域活動。The volume of sampling is 1m3，no operational activitie is carried out in the mean time.?收集平皿，在 37C下培養(yǎng) 48 小時，用 2 個空白培養(yǎng)基做陰性對照，觀察并判定培養(yǎng) 結(jié)果。? Collect the dishes ， cultivate under 37 C for 48h , use 2 empty dishe

55、s for nagtive comparetion.?重復(fù)三次實驗。? Test 3times for reproducibility.E .浮游菌動態(tài)測試 Floating Bacteria Sampler test operational?確認層流正常運轉(zhuǎn)。Verify the lam inar flow running no rmally.?按照操作規(guī)程對設(shè)備內(nèi)表面及操作臺進行清潔及消毒Clea n and dis infect the inner surface and operati ng table as the procedure request beforethe test.?

56、在測試之前運行設(shè)備至少 30 分鐘。Run the equipme nt for at least 30 min before the test.?按照示意圖使用浮游菌采樣器進行采樣。Sample with a Floati ng Bacteria Sampleras the layout described.?用浮游菌采樣器采樣，采樣量為 1 立方米，期間人員在此區(qū)域正?；顒?。The volume of sampling isr 1m3，normal operational activitie should be carried out in themean time.?收集平皿，在 37C

57、下培養(yǎng) 48 小時，用 2 個空白培養(yǎng)基做陰性對照，觀察并判定培養(yǎng) 結(jié)果。? Collect the dishes，cultivate under 37Cfor 48h，use 2 empty dishes for nagtive comparetion.?重復(fù)三次實驗。? Test 3times for reproducibility.1oA0B浮游菌布點圖 Layout of Floating Bacteria Sampler test 可接受標準 Acceptanee Criteria?區(qū)域的靜態(tài)懸浮粒子數(shù)符合中國 GMP C 級區(qū)要求。The at rest airborne part

58、icle count meet with the requirements of Chinese GMP Class C.m： w3520000 particles per m5 m 粒子數(shù)：w29000/m3.5(in:w29000 particles per m?靜態(tài)沉降菌陰性對照培養(yǎng)結(jié)果為 0,其他培養(yǎng)基結(jié)果小于 1 個/皿At rest nagtive comparetion =0 cfu ; other dishesv1 cfu per dish.動態(tài)沉降菌陰性對照培養(yǎng)結(jié)果為 0,其他培養(yǎng)基結(jié)果小于 5 個/皿Operati onal n agtive compareti on =0

59、 cfu ; other dishesv5 cfu per dish.?靜態(tài)浮游菌陰性對照培養(yǎng)結(jié)果為 0,其他培養(yǎng)基結(jié)果小于 1 個/立方米3At rest nagtive comparetion =0 cfu ; other dishesv1 cfu per m .動態(tài)浮游菌陰性對照培養(yǎng)結(jié)果為 0,其他培養(yǎng)基結(jié)果小于 10 個 /皿Operati onal n agtive compareti on =0 cfu ; other dishesv10cfu per dish?測試報告 Test Report?測試結(jié)果填寫在測試報告 6性能確認測試表內(nèi)，如有偏差記錄在偏差報告中Fill the

60、test results in Attachme nt6 performa nee verificati on Test, and record thedeviation (if any) in Deviation Report. 0.5m 粒子數(shù): 0.5m： 5 m 粒子數(shù)：w2900/m3. 5 0.5m 粒子數(shù):w3520000/m 0.512. 驗證事件處理 Validation Events Handling驗證事件指當進行確認/核實或驗證的過程中發(fā)生一個或一系列的錯誤或失敗。驗證事件發(fā)生后通 過事件發(fā)生階段和嚴重性確定風險等級，根據(jù)風險等級采取適當?shù)拇胧?。填寫“驗證事件清單”，并