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kk444555 在 2023-10-17 22:31 回答了问题 EMA: 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 ...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:31 回答了问题 EMA: 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...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:25 回答了问题 计量校准: 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...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:17 回答了问题 cGMP 数据完整性: 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...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:16 回答了问题 cGMP 数据完整性: 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...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:15 回答了问题 cGMP 数据完整性: 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...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:14 回答了问题 cGMP 数据完整性: Can an internal tip or information regarding a quality issue, such as potential data falsification,; kk444555: No. Regardless of intent or how or from whom the information was received, suspected or known falsification or alteration of records required under pa...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:13 回答了问题 cGMP 数据完整性: Is it acceptable to only save the final results from reprocessed laboratory chromatography?; kk444555: No. Analytical methods should be accurate and precise.16 For most lab analyses, reprocessing data should not be regularly needed. If chromatography is...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:11 回答了问题 cGMP 数据完整性: hy has FDA cited use of actual samples during “system suitability”？; kk444555: FDA prohibits sampling and testing with the goal of achieving a specific result or to overcome an unacceptable result (e.g., testing different samples...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:07 回答了问题 cGMP 数据完整性: When does electronic data become a CGMP record?; kk444555: When generated to satisfy a CGMP requirement, all data become a CGMP record.14 You must document, or save, the data at the time of performance to crea...; 赞同0 反对 0 人感谢 0 评论 1 回复

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