kk222333 回复了问题 2024-04-18 17:21

CMA CNAS

问答 医疗器械检验机构的CMA和CNAS资质有何区别？

kk222333:  CMA是China Inspection Body and Laboratory Mandatory Approval的英文缩写，称作实验室资质认定。是依据《中华人民共和国计量法》、《中华人民共和国认证认可条例》等有关法律、法规的规定，对为社会出具公证数据的检验机构进行强制考核的一种手段...

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我是头像 回复了问题 2023-10-21 11:31

FDA

问答 FDA黑名单（import alert）是什么意思？如何解除？

我是头像: FDA工厂审查的直接后果大部分的中国制造商收到美国FDA的审查通知都会比较重视,当然也有部分制造商不了解审查可能会导致的结果，没有给予足够的重视，导致后面三种结果。FDA工厂审查的直接结果会有三种，分别是NAI，VAI和OAI。代码 全称 中文译意NAI - No Action Indicated ...

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ki1314520 回复了问题 2023-10-18 23:03

EMA EU_GMP

问答 基于问卷调查、文件评审、ISO 9000认证、分析测试结果和与供应商的历史经验进行远程评估是否可以接受?

ki1314520: EEA检查员通常不赞成“纸质审计”本身，因为它能提供与现场评估相同的保证水平，但确实接受它们在基于风险的战略中发挥作用。当最近的积极检查信息是可用的，并且在过去已经完成了令人满意的审核时，它们可能特别适用。它们不能取代对原料药供应商的现场审核，但可以作为制造商审核方案内的一项有用的临时和临时措施。

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kk444555 回复了问题 2023-10-17 23:01

EMA

问答 How should design spaceverification approach be addressed in the pharmaceutical quality system?

kk444555: FDA recommends that firms have a writtenplan for when and how to evaluate the need for design space verification undertheir pharmaceutical quality sys...

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kk444555 回复了问题 2023-10-17 23:01

EMA

问答 What is the difference betweenprocess validation and design space verification?

kk444555: Design space verification should not beconfused with process validation. Both take into consideration prior knowledgeand development conclusions and a...

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kk444555 回复了问题 2023-10-17 23:00

EMA

问答 How can a design space beverified at commercial scale for biological products?

kk444555: Principles laid down for chemical productsare applicable to biological products. In addition, verification studies shouldprovide evidence that the qua...

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kk444555 回复了问题 2023-10-17 22:59

EMA

问答 What if unexpectedresults/events are obtained during the design space verification studies?

kk444555: If the verification studies prove theprocess does not meet the predefined product quality attributes in a new regionof the approved design space, this...

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kk444555 回复了问题 2023-10-17 22:58

EMA

问答 How should design spaceverification protocol be addressed in the submission?

kk444555: In principle, a design space verificationprotocol could include the following: list of scale dependent parameters whoseimpact on the CQAs has not been...

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kk444555 回复了问题 2023-10-17 22:57

EMA

问答 How can a design space beverified at commercial scale?

kk444555: It is not necessary to repeat at commercialscale the experiments initially conducted to define a design space at labor pilotscale. Furthermore, it is ...

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kk444555 回复了问题 2023-10-17 22:56

EMA

问答 How is a design space initiallydeveloped and verified at commercial scale?

kk444555: Both Agencies acknowledge that when adesign space is established at early stages of product development, it istypically developed based on experiments...

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kk444555 回复了问题 2023-10-17 22:56

EMA

问答 What is the purpose of design spaceverification at commercial scale?

kk444555: Design space verification demonstrates thatwithin design space boundaries scale-up effects are under control and do notadversely affect the expected p...

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kk444555 回复了问题 2023-10-17 22:54

EMA

问答 Why would a design space beverified during the product lifecycle?

kk444555: In both Agencies’ experience, the designspace verification at commercial scale is not necessarilycomplete at the time of submission of the application...

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kk444555 回复了问题 2023-10-17 22:52

EMA

问答 在同一设施中生产不同物种的兽药时要考虑什么？

kk444555: The guideline on setting health-based exposure limits indicates that the carry over limit should generally be derived using the human HBEL.HBEL设定指南指出一...

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kk444555 回复了问题 2023-10-17 22:52

EMA

问答 杀外寄生虫药物是否可以与其它类别人用或兽用药品在共用设备中生产或进行内包装？

kk444555: If a HBEL cannot be determined or data cannot support manufacture in shared facilities then the Ectoparasiticides should be manufactured in dedicated ...

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kk444555 回复了问题 2023-10-17 22:51

EMA

问答 Is the use of LD50 to determine Health-Based Exposure Limits for drug products acceptable?

kk444555: No, LD50 is not an adequate point of departure to determine a HBEL for drug products.不可以，LD50用于计算药品HBEL是不充分的。

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