R2技术转移文件接收记录TechnologyTransferDocumentReceivingRecord

1、技术转移文件接收记录TeCh no Iogy Tran Sfer DoCUme nt ReCeiVi ng ReCord技术转移编码TT Ref. NUmber技术转移品名PrOdUCt n ame规格Stre ngth剂型DOSage市场Market包装规格PaCkag ing SPeCifiCati onPV计划日期PV Target Date申请人/日期APPIiCa nt/date序号No.名称Name是否接收ReCeiVed or not完整In tegrity确认人/日期 ReCeiVed By PTD/ Sig n &Date1、技术转移方案(提议的)TT Protoco

2、l (Proposed)是YeS 否No N/A是YeS 否No N/A2、原料药质量标准和检验报告APl SPeCifiCatiOn & CoAs是YeS 否No N/A是YeS 否No N/A3、原料药方法验证方案及报告API method VaIidation protocol and report是YeS 否No N/A是YeS 否No N/A4、辅料质量标准及检验报告单EXCiPie nts SPeCifiCati on & CoAs是YeS 否No N/A是YeS 否No N/A5、关键辅料的方法验证(如需)或批准的分析方法MethOd VerifiCati on

3、of CritiCaI excipie nts (If any) or approved method of an alysis是YeS 否No N/A是YeS 否No N/A6、符合供应商批准SOP的所有原辅料供应商批准文件All Ven dor approval docume nts of EXCiPie nts and API accord ing to Ven dor approval SOP是YeS 否No N/A是YeS 否No N/A7、内包材质量标准及检验报告单(安瓿瓶)SPeCifiCati on and CoAs of Primary PaCkag ing material

4、 (AmPOUIe)是YeS 否No N/A是YeS 否No N/A8、内包材(安瓿瓶)检验方法MethOd of Primary PaCkaging material (ampoule)是YeS 否No N/A是YeS 否No N/A9、所有内包材供应商的批准文件All docume nts for Ven dor APPrOVaI of Primary PaCkagi ng materials是YeS 否No N/A是YeS 否No N/A10、产品说明书、标签、纸盒、纸箱等质量标准及检 验报告书SPeCifiCati on and CoAs of PrOdUCt Leaflet, lab

5、el, box, Cart on, etc.是YeS 否No N/A是YeS 否No N/A11、产品传单，标签，盒子，纸箱等的测试方法MethOd of TeSti ng for PrOdUCt Leaflet, label, box, Carton, etc.是YeS 否No N/A是YeS 否No N/A12、最新的说明书和包装标签及修订说明(如有)UPdated PaCkage In Sert and ArtWOrk and justificati on of Cha nges (If n eed)是YeS 否No N/A是YeS 否No N/A13、所有外包材供应商批准文件All d

6、ocume nts for Ven dor approval of Secon dary PaCkagi ng MateriaIS是YeS 否No N/A是YeS 否No N/A序号No.名称Name是否接收ReCeiVed or not完整In tegrity确认人/日期 ReCeiVed ByPTD/ Sig n & Date14、工艺和检测的风险评估RiSk ASSeSSme nt of PrOCeSS and In SPeCti on是YeS 否No N/A是YeS 否No N/A15、工艺特性报告PrOCeSS CharaCteriZati on RePOrt是YeS 否No

7、 N/A是YeS 否No N/A16、生产说明或工艺流程Man UfaCtUri ng In StrUCti on or PrOCeSS order是YeS 否No N/A是YeS 否No N/A17、工艺规程（草稿版）Draft PrOCeSS PrOCedUre是YeS 否No N/A是YeS 否No N/A18、工艺优化方案（草稿版）Draft PrOCeSSOPtimiZati on Protocols是YeS 否No N/A是YeS 否No N/A19、批生产记录&批包装记录（草稿版）Draft BMRand BPR是YeS 否No N/A是YeS 否No N/A20、工艺开

8、发报告（研发，如有）PrOCeSS Development RePOrt （R&D, if any）是YeS 否No N/A是YeS 否No N/A21、成品分析方验证Analytical method development of finiShed PrOdUCtS是YeS 否No N/A是YeS 否No N/A22、成品有关物质分析方法验证Analytical method development of finiShed PrOdUCtS for RS是YeS 否No N/A是YeS 否No N/A23、成品微生物限度、细菌内毒素及无菌检测方法验 证Analytical metho

9、d development of finiShed PrOdUCtS for MLT, Endotoxin & SteriIity test是YeS 否No N/A是YeS 否No N/A24、成品分析方法转移方案Analytical method transfer protocol for finiShed PrOdUCtS是YeS 否No N/A是YeS 否No N/A25、成品分析方法转移报告An alytical method tra nsfer report for fini Shed PrOdUCtS是YeS 否No N/A是YeS 否No N/A26、成品保质期规格Fin

10、ish PrOdUCt Shelf Life SPeCifiCation是YeS 否No N/A是YeS 否No N/A27、杂质清单和工作标准LiSt of ImPUritieS and working Standard是YeS 否No N/A是YeS 否No N/A28、特种化学品，试剂，色谱柱和特种设备信息列表LiSt of SPeCiaI Chemicals, reage nts, colum n & SPeCiaI equipme nt in formati on是YeS 否No N/A是YeS 否No N/A29、稳定性实验包括光照实验方案及报告StabiIity test

11、i ng protocols and report, in cludi ng photo StabiIity StUdy是YeS 否No N/A是YeS 否No N/A30、清洁方法开发方案及报告Clea ning method developme nt protocol and report是YeS 否No NzA是YeS 否No NZA序号No.名称Name是否接收ReCeiVed or not完整In tegrity确认人/日期 ReCeiVed ByPTD/ Sig n & Date31.试验批产品质量标准和检验报告SPeCifiCatiOn & CoAS (DrUg

12、PrOdUCt) three trial batch是YeS 否No N/A是YeS 否No N/A32.容器封闭系统验证方案及报告COntainer closer SyStem VaIidati on protocol and report是YeS 否No N/A是YeS 否No N/A33.模具图纸Tooli ng DraWi ng是YeS 否No N/A是YeS 否No N/A34.EHS要求EHS ReqUireme nt是YeS 否No N/A是YeS 否No N/A35.是YeS 否No N/A是YeS 否No N/A36.是YeS 否No N/A是YeS 否No N/A生产主管的意见Comme nts of PrOdUCti on SUPerViSOr签名和日期Sign & date车间及生产经理意见签字&日期Comments ofWOrkShOP &