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关注: 166 | 粉丝: 53 | 积分: 264748 | 威望: 3 | 访问: 34235

似水流年在 2023-10-17 22:51 发起了提问 EMA: 问答杀外寄生虫药物是否可以与其它类别人用或兽用药品在共用设备中生产或进行内包装？

kk444555: If a HBEL cannot be determined or data cannot support manufacture in shared facilities then the Ectoparasiticides should be manufactured in dedicated ...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:50 发起了提问 EMA: 问答 Is the use of LD50 to determine Health-Based Exposure Limits for drug products acceptable?

kk444555: No, LD50 is not an adequate point of departure to determine a HBEL for drug products.不可以，LD50用于计算药品HBEL是不充分的。; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:50 发起了提问 EMA: 问答简单地在专用区内生产同一类治疗用途的药品进行分隔作为交叉污染风险控制方式是否可接受？

kk444555: Manufacturers cannot just segregate common products from other product types as a means of dealing with the risk to patient and animal safety. A...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:49 发起了提问 EMA: 问答 What are the requirements for conducting visual inspection as per Q&A 7?

kk444555: When applying visual inspection to determine cleanliness of equipment, manufacturers should establish the threshold at which the product is readily vi...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:47 发起了提问 EMA: 问答清洁验证完成之后，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...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:46 发起了提问 EMA: 问答 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...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:45 发起了提问 EMA: 问答委托生产方在支持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...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:44 发起了提问 EMA: 问答 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...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:42 发起了提问 EMA: 问答 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...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:41 发起了提问 EMA: 问答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...; 关注问题 1  0  0 评论

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