PQ认证指南 _ 文件实例 Sample Product Dossier for a CD4 IVD Sample Product Dossier for an HIV RDT, HIV including self-testing Sample Product Dossier for a qualitative nucleic acid-based testing technology for HIV-1 and HIV-2 to detect HIV-1 and HIV-2 Sample Product ...
② 工厂主文件(Site Master File,SMF)-用于现场核查 ③ 样品(product sample)-1)用于产品检验 2)拍照挂网公示说明:每一个模块具有相关的指导原则,感兴趣的小伙伴,可去官网搜索。 04申报 ①PRE-SUBMISSION MEETINGS 可以与WHO就产品质量和BE方面重要的问题进行探讨,有助于完整性审查及加快后续审评进展。感兴趣打开...
Additionally, if a contract research organization (CRO) performed a related study, inspection of that CRO with respect to the particular study, may also be necessary. ② 工厂主文件(Site Master File,SMF)-用于现场核查③ 样品(product sample)-1)用于产品检验2)拍照挂网公示说明:每一个模块具有相关的...
在药品生产企业申请产品审批的时候,通常需要提供一封书面纸质的申请信(acoveringletter)、所申报品种的技术资料(product dossier)、样品(productsample)以及生产场地主控文件(Site Master File)。企业应要按照WH0的申报要求将上述四项内容寄送到WHO药品预认证项目设在丹麦哥本哈根UNICEF供应处(SupplyDivision)的受理办公室。
在药品生产企业申请产品审批的时候,通常需要提供一封书面纸质的申请信(a covering letter)、所申报品种的技术资料(product dossier)、样品(product sample)以及生产场地主控文件(SiteMaster File)。企业应要按照WH0的申报要求将上述四项内 8、容寄送到WHO药品预认证项目设在丹麦哥本哈根UNICEF供应处(Supply Division)的受理...
4.1.There should be a comprehensivelydesigned, clearly defined, documented and correctly implemented quality managementsystem in place. Senior management should assume responsibility for this aswell as the quality of the investigational product. 应具备经过全面设计的、规定明确的、有文件记录的质量管理体系并正...
11.10. The packaging must ensure that the investigational product remains in good condition during transport and storage. Any opening of, or tampering with, the outer packaging during transport should be readily discernible. 包装必须确保试验用...
5)样品(product sample)。 3. WHO对申报资料进行形式审查,如果发现文件缺失,会通知申请者在规定时间内补齐,否则退回申请;如果文件齐全,WHO会发出信函告知文件参考号(dossier reference number),相当于受理号,并告知相应的审核周期。 4. WHO对申报资料进行审核,并决定是否进行现场检查。
12.10The reference sample should be of sufficient size to permit the carrying out on, at least, two occasions of the full analytical controls on the batch in accordance with the Investigational Product dossier submitted for authorization in order to conduct the clinical trial. ...
thefinished product is correctly processed and checked according to the definedprocedures; 成品根据既定程序正确加工和检查 deviations and changes areinvestigated and recorded with an appropriate level of root cause analysis doneand appropriate corrective actions and/or preventive actions (CAPAs) identifiedand...