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kk444555kk444555 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...
文章 PLC调试步骤
很多电气的新手在做完电气控制柜以及plc程序等设计环节后，不清楚调试应如何开始，或者一些人因为不适当的调试方法导致了PLC烧毁等等问题，那么设计完的电气系统应该如何调试？可依照以下七步。1、按照图纸检查回路（未送电状态下）一般PLC系统的图...
PLC
kk444555kk444555 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...
文章 FDA指南：《数据完整性和GMP符合性问答》-2018终稿（中英文对照版）
2018年12月12日，FDA发布了行业指南《Data Integrity and Compliance With Drug CGMP数据完整性和GMP符合性问答》终稿，期中包括18个问题的解答，如下：1. Please clarify t...
cGMP 数据完整性
kk444555kk444555 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...
kk444555kk444555 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...
kk444555kk444555 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...
kk444555kk444555 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...
kk444555kk444555 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...
kk444555kk444555 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...
kk444555kk444555 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...
kk444555kk444555 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...
kk444555kk444555 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...
kk444555kk444555 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...
kk444555kk444555 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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