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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加菲 回复了问题 2023-09-11 11:32

PHSS

问答 什么是PHSS？

加菲: 药物与医疗保健科学协会（Pharmaceutical and Healthcare Sciences Society，简称PHSS）是一个国际性的专业组织，致力于促进药物和医疗保健科学领域的研究、教育和交流。PHSS的成员包括来自学术界、行业界和政府机构的专业人士，他们在药物研发、制造、质量控制、临...

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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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qwe123123 回复了问题 2023-09-05 12:15

TFDA

问答 什么是TFDA？

qwe123123: TFDA是泰国食品药品监督管理局（Thailand Food and Drug Administration），进入泰国的药品，食品，食品补充剂，用于动物保健的产品或其他医学，麻醉和有毒物质均需要在泰国食品药品监督管理局（FDA）注册。由于泰国的国内医疗设备制造商通常只生产基本医疗产品，例如注射器和...

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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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qwe123123 回复了问题 2023-09-05 12:49

TFDA

问答 申请TFDA注册流程是什么？

qwe123123: 1.指定一名泰国法定代表；2. 确定产品是否属于泰国法规规定的医疗器械，确定产品风险分类；3. 准备注册文件，包括自由销售证明及体系证明合规文件4. 提交注册文件，由医疗设备控制部(MDCD)录入至数据库并进行审核；5. 审核通过后获取医疗器械批准书，后合法进入泰国市场销售。

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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 22:54

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 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 22:56

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 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 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 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 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 22:51

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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