【正文】 w Born Bovine Serum Quality Specification 新生牛血清質(zhì)量標(biāo)準(zhǔn)Methotrexate氨甲喋呤Dimethyl Sulphoxide二甲基亞砜Semiproduct of XXX standard, include the Harvest liquid, the Purification liquid and the Bulk.XXX中間品質(zhì)量標(biāo)準(zhǔn)，包括細(xì)胞收獲液、純化產(chǎn)物、原液（文件號(hào)：XXX）Final product of XXX standard XXX成品質(zhì)量標(biāo)準(zhǔn)：（文件號(hào)：XXX）n The validation procedures, items and contents are divided based on the system process steps. The process steps, validation items, sampling methods, testing methods and acceptance criteria are described for each of the process steps.驗(yàn)證的程序、項(xiàng)目和內(nèi)容中以系統(tǒng)工序?yàn)閱挝唬瑢?duì)各工序中的所涉及的工藝步驟、驗(yàn)證項(xiàng)目、取樣方法、檢驗(yàn)方法和接受標(biāo)準(zhǔn)進(jìn)行了規(guī)定和描述。表格 1 縮略語Abbreviations縮略語Definition定義APIActive Pharmaceutical Ingredient (or “Drug Substance”)原料藥（或藥品物質(zhì)）CPPCritical Process Parameter關(guān)鍵工藝參數(shù)CQACritical Quality attribute關(guān)鍵質(zhì)量屬性CVCleaning Validation清洗驗(yàn)證IQInstallation Qualification安裝確認(rèn)MFVMedia Fill Validation培養(yǎng)基模擬灌裝試驗(yàn)N/ANot applicable不適用OQOperation Qualification運(yùn)行確認(rèn)PLCProgrammable Logic Controller可編程邏輯控制器PQPerformance Qualification性能確認(rèn)PVProcess Validation工藝驗(yàn)證PWPurified Water純化水QAQuality Assurance質(zhì)量保證RARisk Assessment風(fēng)險(xiǎn)分析SOPStandard Operation Procedure標(biāo)準(zhǔn)操作程序URSUser Requirement Specification用戶使用要求VMPValidation Master Plan驗(yàn)證主計(jì)劃WFIWater for Injection注射用水6. Protocol Description方案說明n Using this defined process validation shall be performed for the results of the Process Risk Assessment.本方案實(shí)施的工藝驗(yàn)證，是基于工藝風(fēng)險(xiǎn)評(píng)估結(jié)果的。 Process Validation of Protein Manufacturing (Technical Report No. 42 Supplement Vol. 59, No. S4 September/October 2005 169。 A WHO Guide to good manufacturing practice(GMP) requirements , Part 2 Validation , 1997 WHO 關(guān)于GMP要求的指南， 第二部分：驗(yàn)證，1997年252。 SFDA Good Manufacturing Practice (2010 Revision), March, 2011SFDA 藥品生產(chǎn)質(zhì)量管理規(guī)范（2010年修訂），2011年03月252。 FDA 21 Code of Federal Regulations, Part 211, current Good Manufacturing Practice for Finished Pharmaceuticals, April 2011FDA聯(lián)邦法典第21篇第211部分，現(xiàn)行藥物制劑生產(chǎn)質(zhì)量管理規(guī)范，2011年4月252。 EMEA Note for guidance on process validation, September 2001 歐洲藥品管理局 – 工藝驗(yàn)證指南，2001年9月252。 EudraLex Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, November, 2008EudraLex 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252。 Assessment and handling of changes and deviations occur during this process validation負(fù)責(zé)對(duì)工藝驗(yàn)證實(shí)施過程中出現(xiàn)的變更和偏差的評(píng)價(jià)和處理252。 Providing equipment validation reports related to this validation protocol負(fù)責(zé)提供和本驗(yàn)證方案有關(guān)的設(shè)備驗(yàn)證報(bào)告252。 Sampling at each process steps during the process validation負(fù)責(zé)工藝驗(yàn)證中各工序的取樣252。 Final report Review 最終報(bào)告的審核n Quality assurance of quality department 質(zhì)量部質(zhì)量保證252。 Providing technical supports and guidance for tests at each of the process steps負(fù)責(zé)各工序檢驗(yàn)的技術(shù)支持和指導(dǎo)252。 Validation of the necessary test methods for XXXXX involved in this validation protocol負(fù)責(zé)本驗(yàn)證方案涉及的重組乙型肝炎疫苗（CHO細(xì)胞）原液生產(chǎn)的必要的檢驗(yàn)方法的驗(yàn)證252。 Final report Review 最終報(bào)告的審核n Quality control of quality department 質(zhì)量部質(zhì)量控制252。 Calibration of instruments related to this validation protocol and providing relevant calibration certificates and quality certificates負(fù)責(zé)校驗(yàn)和本驗(yàn)證方案有關(guān)的儀器、儀表，出具校驗(yàn)報(bào)告并貼合格證252。n Utility support department 工程服務(wù)部252。 Training of personnel based on this validation protocol按驗(yàn)證方案對(duì)有關(guān)人員進(jìn)行培訓(xùn)252。 Review relevant quality criteria including raw material, intermedia and finished product審核原輔料標(biāo)準(zhǔn)、中控質(zhì)量標(biāo)準(zhǔn)和成品的質(zhì)量標(biāo)準(zhǔn)n Vaccine one Plant 疫苗一室252。 Provide product registration criteria and review whether recipe and process step described in the protocol is plying with registered criteria提供產(chǎn)品的注冊(cè)工藝，審核方案中生產(chǎn)處方、工藝與注冊(cè)資料的一致性252。 Assure all the equipment used for validation can be maintained timely保證驗(yàn)證用所有設(shè)備均能按SOP進(jìn)行及時(shí)的維護(hù)和保養(yǎng)252。 Final report Review/ Analyze and pile data into the summary report最終報(bào)告的審核/對(duì)數(shù)據(jù)進(jìn)行分析并將其編輯入總結(jié)報(bào)告之中 XXX responsibilities XXX的職責(zé)n Production department 生產(chǎn)部252。 Compile Protocol方案的編寫252。The labeling and packaging processes are not within the scope of this document since these processes have been validated per PQ protocol (labeling) and PQ protocol (packaging), and these processes have minimal impact on finished product quality. 貼標(biāo)簽和包裝也不在此文件范圍內(nèi)，因?yàn)檫@些工藝已經(jīng)按照PQ方案（貼標(biāo)簽）和PQ方案(包裝)驗(yàn)證過，并且這些工藝對(duì)產(chǎn)品質(zhì)量極少有影響。2. Scope范圍This protocol is applicable to the process validation of XXX produced by the equipment located XXX.本方案適用于XXX原液生產(chǎn)的工藝驗(yàn)證。Protocol XXXXXX工藝驗(yàn)證方案Written by起 草 人Written date起草日期年 月 日Reviewed by審 核 人Reviewed date審核日期年 月 日Approved by批 準(zhǔn) 人Approved date批準(zhǔn)日期年 月 日Written department起草部門Effective date生效日期年 月 日Issued by:頒發(fā)部門： [ ]Copy number:拷 貝 號(hào)： [ ]Change record:Revision number變更記載： Date of approval Effective date修訂號(hào) 批準(zhǔn)日期 生效日期 Change reason and goal: 變更原因及目的：Distribution department:分發(fā)部門:所長辦公室[ ] 人力資源部[ ] 后勤保衛(wèi)部[ ] 物資供應(yīng)部[ ] 工程服務(wù)部[ ]生產(chǎn)管理部[ ] 質(zhì)量保證部[ ] 銷 售 部[ ] 倉 儲(chǔ) 部[ ] 疫苗一室[ ]疫苗二室[ ] 疫苗三室[ ] 疫苗五室[ ] 疫苗六室[ ] 生化制品室[ ]細(xì)胞因子室[ ] 血清制品室[ ] 實(shí)驗(yàn)動(dòng)物室[ ] 分包裝室[ ] 培養(yǎng)基室[ ] Verification department (department): 驗(yàn)證科室（部門）： Verify名稱TitleProcess Validation (PV)Protocol for XXXXXX工藝驗(yàn)證方案Doc. No.文件編號(hào)Page頁碼Process Validation (PV)pletion date: 驗(yàn)證完成日期： Validity: 有 效 期： Index 目錄1. Purpose目的 52. Scope范圍 53. Responsibility職責(zé) 5 AAA responsibilities AAA的職責(zé) 5 XXX responsibilities XXX的職責(zé) 64. Regulation and Guidance 法規(guī)和指南 85. Abbreviations縮略語 96. Protocol Description方案說明 117. Product And Process Description產(chǎn)品和工藝描述 14 Product specification 14 Drug approval No. 14 Standard Followed: 14 Raw Materials and Adjuvants原輔料情況 14 Process description: 16 Process Recipe工藝處方： 21 List of Production Plants生產(chǎn)車間一覽 26 List of Production Equipment 生產(chǎn)設(shè)備一覽 29 Process Flow Diagram 工藝流程圖 33 CPP Identification CPP確認(rèn) 34