kk444555 回复了问题 2023-10-17 22:31

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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kk444555 回复了问题 2023-10-17 22:31

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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kk444555 回复了问题 2023-10-17 22:25

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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kk444555 回复了问题 2023-10-17 22:17

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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kk444555 回复了问题 2023-10-17 22:16

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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kk444555 回复了问题 2023-10-17 22:15

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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kk444555 回复了问题 2023-10-17 22:14

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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kk444555 回复了问题 2023-10-17 22:13

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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kk444555 回复了问题 2023-10-17 22:11

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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kk444555 回复了问题 2023-10-17 22:07

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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kk444555 回复了问题 2023-10-17 22:06

cGMP 数据完整性

问答 Can I use electronic signature instead of handwritten signature?

kk444555: Yes, electronic signatures with the appropriate controls can be used instead of handwritten signatures or initials in any CGMP required record. Althou...

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kk444555 回复了问题 2023-10-17 22:05

cGMP 数据完整性

问答 Is it acceptable to save paper printed records instead of original electronic records?

kk444555: A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original record (see §§ 211.68...

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kk444555 回复了问题 2023-10-17 22:03

cGMP 数据完整性

问答 Can electronic copies be used as accurate reproductions of paper or electronic records?

kk444555: Yes. Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original...

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kk444555 回复了问题 2023-10-17 22:01

cGMP 数据完整性

问答 How often should audit trails be reviewed?

kk444555: If the review frequency for the data is specified in CGMP regulations, adhere to that frequency for the audit trail review. For example, § 211.188(b) ...

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kk444555 回复了问题 2023-10-17 22:00

cGMP 数据完整性

问答 Who should review audit trails?

kk444555: Audit trail review is similar to assessing cross-outs on paper when reviewing data. Personnel responsible for record review under CGMP should review t...

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