kk444555 回复了问题 2023-10-17 22:50

EMA

问答 简单地在专用区内生产同一类治疗用途的药品进行分隔作为交叉污染风险控制方式是否可接受？

kk444555:  Manufacturers cannot just segregate common products from other product types as a means of dealing with the risk to patient and animal safety. A...

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kk444555 回复了问题 2023-10-17 22:47

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...

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kk444555 回复了问题 2023-10-17 22:46

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...

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kk444555 回复了问题 2023-10-17 22:44

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...

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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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