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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

似水流年在 2023-10-17 22:31 发起了提问 EMA: 问答活性物质标准是否需要明确在生产过程中使用了鱼蛋白胨，并且组胺是控制在协定范围内的特定杂质？

kk444555: Yes.If fish peptone is used in the fermentation process there is a potentialserious risk to public health if it is contaminated with high levels ofhis...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:30 发起了提问 EMA: 问答在发酵过程中，生产活性物质所使用的任何蛋白胨(如动物或植物来源)的来源是否必须列入相关档案？

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

似水流年在 2023-10-17 22:24 发起了提问 计量校准: 问答哪些仪器需要校准？哪些仪器不需要校准？

kk444555: Calibration Determination校准决定An effective calibration program must firstidentify which items must be calibrated. The following items must becalibrated...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:17 发起了提问 cGMP 数据完整性: 问答 How does FDA recommend data integrity problems be addressed?

kk444555: FDA encourages you to demonstrate that you have effectively remediated your problems by investigating to determine the problem’s scope and root causes...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:16 发起了提问 cGMP 数据完整性: 问答 Is FDA allowed to look at electronic records?

kk444555: Yes. All records required under CGMP are subject to FDA inspection. This applies to records generated and maintained on computerized systems, includin...; 关注问题 1  0  0 评论

似水流年在 2023-10-17 22:15 发起了提问 cGMP 数据完整性: 问答 Should personnel be trained in preventing and detecting data integrity issues

kk444555: Yes. Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under §§ 211.25 and 212.10, which st...; 关注问题 2  0  0 评论

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