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关注: 23 | 粉丝: 33 | 积分: 328 | 威望: 0 | 访问: 2016

kk444555 在 2023-10-17 22:47 回答了问题 EMA: 清洁验证完成之后，共用设施里的设备中更换产品时是否需要进行分析检测？; kk444555: Analytical testing is expected at each changeover unless justified otherwise via a robust, documented Quality Risk Management (QRM) process. The QRM p...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:46 回答了问题 EMA: How can limits for cleaning purposes be established?; kk444555: Although the EMA guideline (EMA/CHMP/CVMP/SWP/169430/2012) may be used to justify cleaning limits (as per Introduction paragraph 3), it is not intende...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:45 回答了问题 EMA: 委托生产方在支持HBEL评估的数据方面有什么职责？; kk444555: Contract givers should either provide a full HBEL assessment to contract manufacturers or provide the data to allow the contract manufacturer to condu...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:44 回答了问题 EMA: What competencies are required for the person developing the Health-Based Exposure Limits (HBEL)?; kk444555: Health-Based Exposure Limits should be determined by a person who has adequate expertise and experience in toxicology/pharmacology, familiarity with p...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:43 回答了问题 EMA: How should manufacturers use the HBELs?; kk444555: The role of HBELs in determining cleaning limits is explained in Q&A 6. However, the purpose of generating HBELs goes beyond justification of clea...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:42 回答了问题 EMA: 有什么框架可以用来确定HBEL，用以广泛指导质量风险管理（QRM）的程度和是否需要控制措施？; kk444555: Firstly, it should be recognised that hazard varies on a continuum scale and that there are no firm cut off points, risk should be controlled on a pro...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:41 回答了问题 EMA: Are Health-Based Exposure Limits (HBELs) required for all medicinal products?; kk444555: Yes, HBELs should be established for all medicinal products. The toxicological or pharmacological data, on which the HBEL calculation relies, requires...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:40 回答了问题 EMA: 生产过程中使用的设备变更，公司质量保证体系 (GMP) 涵盖哪些变更？; kk444555: Provided thatthe new equipment isequivalent to the one currently used, and operates in theapproved range ofprocess parameters, the change is covered b...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:39 回答了问题 EMA: 生产基地、厂房和房间的哪些变更可以由公司质量保证体系 (GMP) 覆盖？; kk444555: Provided thatmodule 3 is not impacted, withthe exception of section 3.2.A.1 (forbiological medicinalproducts), the changeslisted below (not an exhaust...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:36 发表了文章: 文章 2024年卫生资格考试报考条件及工作年限对照表！

新一轮备考周期开始啦！有很多考生不清楚自己符不符合2024年卫生资格报考条件，因此小编为大家整理了2024年卫生资格考试报名条件及工作年限对照表，想报名的考生，记得收藏对照下哦！护/药/技报考条件说明...; 赞同0  209 浏览  0 评论 kk444555 2023-10-17 22:36

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