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关注: 166 | 粉丝: 53 | 积分: 264608 | 威望: 3 | 访问: 23350

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

似水流年在 2023-10-17 22:40 发起了提问 EMA: 问答 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...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:39 发起了提问 EMA: 问答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...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:39 发起了提问 EMA: 问答生产基地、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...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:32 发起了提问 EMA: 问答如果原料药生产的发酵工艺中使用了蛋白胨（例如动物和植物来源），是否需要放在相关注册资料中？

kk444555: Yes. Peptone is considered to be a critical raw material, whose origin (animal or vegetable) and source (supplier name and address) should be specifie...; 关注问题 1  0  0 评论

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