感兴趣打开如下链接,具体了解:https://extranet.who.int/pqweb/sites/default/files/documents/note_pre-submission_meetings.pdf② 提交形式(1)CTD资料电子版,平台提交,例如“WeTransfer 平台”(2)DVD提交通常采用“(1)”递交方式。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...
参与PQ认证的优势在于,一来可成为联合国采购供应商;二来WHO一次性审评,可在多个发展中国家上市,提高上市效率;三来参与PQ预认证,可得到专家顾问协助,快速提升企业体系达到国际水平,更好的服务发展中国家患者。 流程Procedure for prequalification of pharmaceutical products--WHO Technical Report Series, No. 961, 20...
(1)Manufacture site: PQ文件受理后6个月内启动现场检查,在现场检查前1-2个月发布现场检查的通知。核查后,30天内形成检查报告提供申请人; 申请人30天内提交CAPA措施文件(通常不超过两次);根据CAPA文件充分性,决定是否开展二次核查:需要二次核查在6个月内完成,如不符合要求,决定核查不通过;不需要二次核查,在后续...
extranet.who.int/pqweb/ 如下图: 02、关于Guidance Documents查询 WHO指导文件分为三种形式。 查询网址: extranet.who.int/pqweb/ 如下图: 接下来,将三种形式的指导文件分别介绍如下:--Technical Report Series (TRS) documents approved by the WHO Expert Committee on Specifications for Pharmaceutical Preparat...
It is recommended that the applicant consults WHO PQ in advance when planning the submission(address enquiry to: prequalvariation@who.int). 建议申请人在计划此类递交前提前咨询WHO PQ(咨询邮箱:prequalvariation@who.int) 6. May a batchsize that has been accepted for one of the approved ...
3.3Theuseofthesystemsfollowinganinitialqualificationsuchasinstallationqualification(IQ),operationalqualification(OQ),performancequalification(PQ)andvalidationshouldbeapprovedbythequalityunit,e.g.qualityassurance(QA). 在初始确认(例如安装确认、运行确认、性能确认和验证)后,系统的使用应由质量部门批准, ...
https://extranet.who.int/pqweb/medicines/products-eligible-prequalification 如下图: 02 关于Guidance Documents查询 WHO指导文件分为三种形式。 查询网址: https://extranet.who.int/pqweb/medicines/WHOguidance-documents 如下图: 接下来,将三种形式的指导文件分别介绍如下: ...
性能确认(PQ) Documented verification that the equipment or systemperforms consistently and reproducibly within definedspecifications and parameters in its normal operating environment (i.e. in theproduction environment). 证明设备或系统性能在正常操作环境下(即生产环境下)持续重复满足既定 标准和参数的文件化工...
performance qualification (PQ). Documented verification that the equipment or system performs consistently and reproducibly within defined specifications and parameters in its normal operating environment (i.e. in the production environment)....
新型冠状病毒肺炎疫情爆发之前或期间进行的WHO PQ检查的CAPA答复,需要在规定的期限内提交。但是,如果有正当理由,组织可以联系相应的检查小组,请求延长CAPA提交的期限。 1.7. Would WHO PQT/INS encourage a more structured meeting to discuss pending inspection issues with organizations, via suitable online communicat...