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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...
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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 ...
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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...
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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...
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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...
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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...
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似水流年
在 2023-10-17 22:14 发起了提问
cGMP
数据完整性
问答
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...
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似水流年
在 2023-10-17 22:13 发起了提问
cGMP
数据完整性
问答
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...
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似水流年
在 2023-10-17 22:11 发起了提问
cGMP
数据完整性
问答
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...
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似水流年
在 2023-10-17 22:07 发起了提问
cGMP
数据完整性
问答
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...
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