kk444555 回复了问题 2023-10-17 21:59

cGMP 数据完整性

问答 How should blank forms be controlled?

kk444555: There must be document controls in place to assure product quality (see §§ 211.100, 211.160(a), 211.186, 212.20(d), and 212.60(g)). For example, bound...

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kk444555 回复了问题 2023-10-17 21:57

cGMP 数据完整性

问答 Why is FDA concerned with the use of shared login accounts for computer systems?

kk444555: When login credentials are shared, a unique individual cannot be identified through the login and the system would not conform to the CGMP requirement...

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kk444555 回复了问题 2023-10-17 21:56

cGMP 数据完整性

问答 How should access to CGMP computer systems be restricted?

kk444555: You must exercise appropriate controls to assure that changes to computerized MPCRs or other CGMP records or input of laboratory data into computerize...

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kk444555 回复了问题 2023-10-17 21:55

cGMP 数据完整性

问答 Does each CGMP workflow on a computer system need to be validated?

kk444555: Yes, a CGMP workflow, such as creation of an electronic master production and control record (MPCR), is an intended use of a computer system to be che...

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kk444555 回复了问题 2023-10-17 21:54

cGMP 数据完整性

问答 Determining CGMP data as invalid is not considered as a judgment of batch conformity?

kk444555: Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see §§ 211.22 and 212.70) and maintained for ...

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kk444555 回复了问题 2023-10-17 21:50

cGMP 数据完整性

问答 What are the “systems” in “computer or related systems” in § 211.68?

kk444555: The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific functions....

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kk444555 回复了问题 2023-10-17 21:49

cGMP 数据完整性

问答 How does FDA use the term “backup” in § 211.68(b)?

kk444555: FDA uses the term backup in § 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention per...

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kk444555 回复了问题 2023-10-17 21:49

cGMP 数据完整性

问答 How does FDA use the terms “static” and “dynamic” as they relate to record formats?

kk444555: For the purposes of this guidance, static is used to indicate a fixed-data record such as a paper record or an electronic image, and dynamic means tha...

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kk444555 回复了问题 2023-10-17 21:41

cGMP 数据完整性

问答 What is an “audit trail”?

kk444555: For purposes of this guidance, audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the co...

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kk444555 回复了问题 2023-10-17 21:40

cGMP 数据完整性

问答 What is “metadata”?

kk444555: Metadata is the contextual information required to understand data. A data value is by itself meaningless without additional information about the dat...

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kk444555 回复了问题 2023-10-17 21:39

cGMP 数据完整性

问答 What is “data integrity”?

kk444555: For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate da...

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ki1314520 回复了问题 2023-10-17 11:35

无源医疗器械

问答 无源医疗器械产品原材料变化形式有哪些？

ki1314520: 一般来说，产品原材料发生改变一般包括以下几种情形 :一是原材料类型的改变，如管路类材料由聚氯乙烯变成聚氨酷等;二是材料组分和/或配比发生改变，如聚氯乙烯材料中增塑剂、抗氧化剂的成分和/或比例改变，虽然材料类型仍为聚氯乙烯，但材料的性能已经完全不同:三是材料制备工艺的改变，比如某些橡胶材料的硫化工艺、...

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ki1314520 回复了问题 2023-10-17 11:29

医疗器械技术评审

问答 对于能量治疗类设备，应如何提交量效关系和能量安全的研究资料？

ki1314520: 对于向患者提供能量或物质治疗的医疗器械，通常需要提供量效关系和能量安全的研究资料，证明治疗参数设置的安全性、有效性、合理性，并反映出能量和组织的作用效果和对应关系，以及除预期靶组织外，能量不会对正常组织造成不可接受的伤害。量效关系及能量安全研究应为申报产品的非临床试验（台架试验、离体组织试验、活体动...

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ki1314520 回复了问题 2023-10-17 11:27

医疗器械技术评审

问答 柠檬酸消毒液有效期验证需检测哪些项目？

ki1314520: 　根据GB 27949-2020《医疗器械消毒剂通用要求》规定，包装完好的产品有效期应不低于12个月。检测项目参考技术要求中相应条款，如各主要有效成分含量（存放后含量下降应≤10%，且存放后主要有效成分含量均不应低于产品技术要求规定含量的下限值）、杀灭微生物指标、外观（包括有无颜色变化、有无沉淀或悬...

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ki1314520 回复了问题 2023-10-17 11:26

医疗器械技术评审

问答 已注册产品的结构组成中包含主机和附件（耗材），现主机已停产，是否可申请变更注册删除主机，仅保留附件以适配现有主机的配合使用需求？

ki1314520: 　首先需根据《医疗器械注册单元划分指导原则》来判定，删除主机后所保留的附件是否可作为同一注册单元。　　如果可以，在保持原有配合使用关系不变的情况下可申请变更注册，从结构组成中删除主机，保留附件。同时需修改产品名称，与附件名称保持一致；修改产品适用范围，明确与原主机型号配合使用。产品技术要求中除附件相...

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