1、approval and authorization批準(zhǔn)和授權(quán)completion of the following signature blocks signifies the review and approval of this document完成以下簽字意味著完成了對(duì)此文件的回顧和批準(zhǔn)name姓名job title/role 職位/角色signature 簽字date 日期the author is signing to confirm that this document has been prepared in accordanee with an approved docume

2、nt management process that content is consistent with the deliverable definition found in the sopxxxx site validati on approach, and that releva nt in put from any con tributary authors has been in eluded 作者的簽字證明文件是按照批準(zhǔn)的文件管理規(guī)程準(zhǔn)備的，其中內(nèi)容符合sopxxxx工廠驗(yàn)證流程對(duì)驗(yàn) 證文件的定義。并確認(rèn)相關(guān)人員的意見(jiàn)均已包含在文件中后簽署文件。validation engine

3、ercompliance & validation are signing to confirm compliance with applicable pharmaceutical regulatory agency requirements and company standards 法規(guī)和驗(yàn)證的簽字確認(rèn)其符合制藥法規(guī)組織的要求和公司標(biāo)準(zhǔn)。validation managerquality managersite director is signing to confirm projects in site and provide the required resources for

4、 validation activities.工廠總監(jiān)的簽字是確認(rèn)工廠需要進(jìn)行的項(xiàng)目和為工廠驗(yàn)證活動(dòng)提供需要的資源。site directordistribution list 分發(fā)清單 no distribution required 不需要分發(fā) field execution copy在執(zhí)行過(guò)程中需要復(fù)印件copy no 復(fù)印件編號(hào)issued to (name / department) 交給(姓名/部門)issued by (c&v) 由誰(shuí)生效(法規(guī)和驗(yàn)證組)date of issue 生效日期123目錄 content1 目白勺 objective32 驗(yàn)證的指導(dǎo)方針與規(guī)程

5、validation polices and procedures43 責(zé)任 responsibilities54 驗(yàn)證的時(shí)間表與進(jìn)展 schedules and progress75 2007 年度完成的驗(yàn)證項(xiàng)目 validation projects completedin200796 2007 年度暫停和取消的驗(yàn)證項(xiàng)目 validation projectsonholdand cancelled in 2007107 修訂歷史 revision history131 目的 objective該工廠驗(yàn)證總計(jì)劃是為了提供一個(gè)對(duì)xxxx公司制藥有限公司的驗(yàn)證工作的綜合描述。具體而言，該 計(jì)劃將

6、：the purpose of the svmp is to provide a comprehensive overview of all validation activities in xxxx 公司.the plan will cover following:1）列出公司在進(jìn)行驗(yàn)證工作時(shí)所必須遵循的指導(dǎo)方針與指南。list the governing policies and procedures that must be followed in validation activities.2）確定公司各部門和主要管理人員在驗(yàn)證工作中的主要責(zé)任。define the responsib

7、ilities of key personnel in validation activities.3）列出公司目前主要的驗(yàn)證工作類別以及與其相關(guān)的驗(yàn)證主計(jì)劃。list the main validation activities in the site and the references to the validation master plans.4）描述公司目前正在進(jìn)行和計(jì)劃將要進(jìn)行的驗(yàn)證工作和項(xiàng)目的程序和進(jìn)展。describe the execution status of validation activities that are in process or in plan.2

8、驗(yàn)證的指導(dǎo)方針與規(guī)程 validation polices and procedures生產(chǎn)廠關(guān)鍵規(guī)程列表如下:key site procedures are listed in the table below.文件名稱document name文件編號(hào)sop number工廠驗(yàn)證管理規(guī)程 site validation approach分析儀器驗(yàn)證通則analytical equipment validation approach化學(xué)檢驗(yàn)方法驗(yàn)證規(guī)程chemical analysis method validation approach生產(chǎn)設(shè)施驗(yàn)證規(guī)程manufacturing facili

9、ty validation驗(yàn)證草案和報(bào)告的生成generation of qualification protocols and reports設(shè)計(jì)確認(rèn)程序validation procedure for design qualification安裝確認(rèn)程序validation procedure for installation qualification運(yùn)行確認(rèn)程序validation procedure for operational qualification性能確認(rèn)程序validation procedure for performanee qualification計(jì)算機(jī)驗(yàn)證方法c

10、omputer validation approach清潔驗(yàn)證cleaning validation維護(hù)系統(tǒng)的驗(yàn)證狀態(tài)maintaining systems the validated status控制系統(tǒng)control system validation approach系統(tǒng)影響性評(píng)估system impact assessment3 責(zé)任 responsibilities部門從員department/personnel責(zé)任responsibility質(zhì)量保證部驗(yàn)證組qa validation 負(fù)責(zé)制訂與回顧年度svmpresponsible for preparing and review

11、ing svmp 負(fù)責(zé)制訂與回顧各項(xiàng)目驗(yàn)證主計(jì)劃responsible for preparing and reviewing vmp of every project 協(xié)調(diào)各個(gè)驗(yàn)證過(guò)程并參與評(píng)估待驗(yàn)證項(xiàng)目co-ordinate all validation processes and, participates in the assessment of prospective projects for validation requirements. 組織與驗(yàn)證相關(guān)培訓(xùn)organize the training for validation.對(duì)驗(yàn)證主計(jì)劃、方案及報(bào)告進(jìn)行審核并將已完成的驗(yàn)證文

12、件存檔review validation master plan, validation protocols and reports, archive validation documents.物資管理部logistic起草倉(cāng)庫(kù)相關(guān)項(xiàng)目的用戶需求標(biāo)準(zhǔn)、方案與報(bào)告prepare the urs, validation protocols and reports for projects of warehouse.進(jìn)行驗(yàn)證前的評(píng)估system assessment before validation按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)證execute validation activities followin

13、g approved validation protocol. 數(shù)據(jù)匯總及對(duì)在驗(yàn)證過(guò)程產(chǎn)生的問(wèn)題進(jìn)行調(diào)查data collection and problem investigation during validation.工程部engineering department起草公用設(shè)施與設(shè)備的用戶需求標(biāo)準(zhǔn)、方案與報(bào)告prepare the urs, validation protocols and reports for facilities and utilities.進(jìn)行驗(yàn)證前的評(píng)估system assessment before validation按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)證execute

14、 validation activities following approved validation protocol.數(shù)據(jù)匯總及對(duì)在驗(yàn)證過(guò)程產(chǎn)生的問(wèn)題進(jìn)行調(diào)查data collection and problem investigation during validation.技術(shù)部 tech nical起草新產(chǎn)品和產(chǎn)品轉(zhuǎn)移的方案與報(bào)告prepare validation protocols and reports for new products and products transfer進(jìn)行驗(yàn)證前的評(píng)估system assessment before validation按批準(zhǔn)的驗(yàn)證

15、方案執(zhí)行驗(yàn)證execute validation activities following approved validation protocol. 數(shù)據(jù)匯總及對(duì)在驗(yàn)證過(guò)程產(chǎn)生的問(wèn)題進(jìn)行調(diào)查data collection and problem investigation during validation.對(duì)工藝驗(yàn)證草案/報(bào)告進(jìn)行批準(zhǔn)approve process validation protocol and report價(jià)值流value stream起草生產(chǎn)設(shè)備與工藝的用戶需求標(biāo)準(zhǔn)、方案與報(bào)告prepare product equipment and process urs, vali

16、dation protocols and reports進(jìn)行驗(yàn)證前的評(píng)估部門從員department/personnel責(zé)任responsibilitysystem assessment before validation按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)證execute validation activities following approved validation protocol.數(shù)據(jù)匯總及對(duì)在驗(yàn)證過(guò)程產(chǎn)生的問(wèn)題進(jìn)行調(diào)查data collection and problem investigation during the validation.實(shí)驗(yàn)室qc lab起草分析儀器及分析方法的用戶需

17、求標(biāo)準(zhǔn)、方案與報(bào)告prepare analytical equipment and test methods urs, validation protocols and reports進(jìn)行驗(yàn)證前的評(píng)估system assessment before validation完成在驗(yàn)證過(guò)程中涉及的檢驗(yàn)并提供及時(shí)準(zhǔn)確的數(shù)據(jù)complete the test in the validation activities and provide timely accurate data.按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)證execute validation activities following approved v

18、alidation protocols數(shù)據(jù)匯總及對(duì)在驗(yàn)證過(guò)程產(chǎn)生的問(wèn)題進(jìn)行調(diào)查data collection and problem investigation during the validation.質(zhì)量保證部qa組 確保驗(yàn)證按照批準(zhǔn)的方案進(jìn)行ensure the validation is executed according to the validation protocol 參與對(duì)在驗(yàn)證過(guò)程中產(chǎn)生的問(wèn)題的調(diào)查take part in problem investigation during validation.質(zhì)量保證部經(jīng)理 head of quality確保所有的驗(yàn)證活動(dòng)符合

19、xxxx集團(tuán)及所涉及市場(chǎng)的法規(guī)部門的要求 ensure all the validation activities comply with the and site procedures批準(zhǔn)svmp,驗(yàn)證主計(jì)劃、工藝驗(yàn)證的方案與報(bào)告、清潔驗(yàn)證草案和報(bào) 告、項(xiàng)目cgmp回顧報(bào)告、驗(yàn)證總結(jié)報(bào)告approve svmp, vmp, performs nee qualification protocol and report, cleaning validation protocol and report, project cgmp review report validation summary r

20、eport工廠總監(jiān) site director扌比準(zhǔn)svmpapprove svmp 為驗(yàn)證工作提供必要的人力資源及財(cái)力資源provide the required resources for validation activities4 驗(yàn)證的時(shí)間表與進(jìn)展 schedules and progress4.1 某車間的驗(yàn)證項(xiàng)目 validation projects in a workshop項(xiàng)目validation projects計(jì)劃開(kāi)始與完成日期scheduled date開(kāi)始日期完成日期ending項(xiàng)目進(jìn)程schedule20072008(6 7 8 9 1011""

21、;"12 1| 2 i 3| 4 5posipon 17|>曠 comp-2.i 進(jìn)行 progres s as per schedu-依據(jù)&備注justifications &comments2006.11oh""，2007.102007.22008.12©2007.42007.42007.12:十:s i1 11- 二iiii1ii1iis:：y：y m§2007424.2某車間回顧驗(yàn)證the re項(xiàng)目validation projects計(jì)劃開(kāi)始與完成日期 scheduled date 開(kāi)始日期丨完成日期項(xiàng)目進(jìn)程sc

22、hedule20072008startingending2007.92007.122008.12008.32008.42008.6789 1023451xx11：!124.3 物流部新項(xiàng)目 logistics new projects項(xiàng)目validation projects如ting計(jì)劃開(kāi)始與完成日期 scheduled date完成日期 ending項(xiàng)目進(jìn)程schedule200720086l 7l 8 i 9l 10 i 11 i 12 i ll 2 i 3 i 4progress as per ;jl-lposiponfe-171月comp-ei書(shū)、n址冠-tz1推遲依據(jù)&備注

23、justifications &comments2006.62006.81 2007.122008.12sv:-:-:-?:-:-:-?:-:-:-4.4 物流部回顧驗(yàn)證 logistics re-validation projects4.5 工程部回顧驗(yàn)證 engineering re-validation projectsqj4.6 工程部支持膠囊價(jià)值流回顧驗(yàn)證的項(xiàng)目 engineering support projects for capsule vs re-validation projects依次羅列出所有部門的驗(yàn)證項(xiàng)目。5.相關(guān)部門完成的驗(yàn)證項(xiàng)目項(xiàng)目validation p

24、rojects計(jì)劃開(kāi)始與完成日期 scheduled date項(xiàng)目進(jìn)程scheduleprogress as perit g： complete推遲 pos-oone d依據(jù)&備注justificati ons& comments開(kāi)始日期 starting完成日期 ending20072006.112007.8-ayvx2006.62007vjx5.2質(zhì)量保證部qa組2007年度完成的驗(yàn)證項(xiàng)目pn projects completed in 2007 qa5.1 工程部 2007 年度完成的驗(yàn)證項(xiàng)目 validation projects completed in 2007熔g

25、ineeringna5.3 質(zhì)量保證部實(shí)驗(yàn)室 2007 年度完成的驗(yàn)證項(xiàng)目 validation projects completed in 2007- qc laboratories計(jì)劃開(kāi)始與完成日期scheduled datexxxx產(chǎn)品軟膏清洗驗(yàn)證分析方法驗(yàn) 證(系統(tǒng)參考編號(hào)302052)fenbid cream cleaning-validation analytical method validation(system reference no.302052)xxxx產(chǎn)品清洗驗(yàn)證分析方法驗(yàn)證 (系統(tǒng)參考編號(hào)302058)xxxx 產(chǎn)品 ointment cleaning-valida

26、tion analytical method validation (system reference no.302058)xxxx產(chǎn)品清洗驗(yàn)證分析方法驗(yàn)證 (系統(tǒng)參考編號(hào)302054)xxxx 產(chǎn)品 cleaning-validation an alytical method validati on (system reference no.302054)xxxx產(chǎn)品清洗驗(yàn)證分析方法驗(yàn)證 (系統(tǒng)參考編號(hào):302061)xxxx 產(chǎn)品 cleaning-validation an alytical method validati on (system referenee n0.:302061)

27、項(xiàng)目進(jìn)程schedule行20072006.102007.32007.12007.22006.112007.12007.107.2licmtion projects on hold and cancelled in 2007a s開(kāi)始日期 starting完成日期 endingxxxx依據(jù) justifications < commentscd項(xiàng)目validation projects計(jì)劃開(kāi)始與完成日期 scheduled date項(xiàng)目進(jìn)程scheduleprogress1)/)ndrcomplete依據(jù)justifications & comments開(kāi)始日期 starti ng完成日期ending20076. 2007年度暫停和取消的驗(yàn)證6.1某車間o項(xiàng)目validation projects計(jì)劃開(kāi)始與完成日期 scheduled date項(xiàng)目進(jìn)程scheduleih pro