kk444555 回复了问题 2023-10-17 23:11

EU_GMP

问答 可以自愿申请对活性物质生产商进行检查吗？

kk444555: 先，只能使用符合GMP要求下生产的原料药是生产许可持有人的责任。法令2001/83/EC第111条（兽药法令2001/82/EC第80条）规定，在活性物质生产商提出特殊申请后，成员国药监局再进行原料药的检查。检查申请应向生产商所在国EEA合法药监机构提出，如果工厂地址位于第三国，则可以向活性物质用作...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 23:10

EU_GMP

问答 How do the new requirements affect importers of medicinal products?

kk444555: Importers are manufacturing-authorisation holders and so the obligations under Article46f/50f of Directive 2001/83(2) apply to them. For importers, th...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 23:09

EU_GMP

问答 采用远程评估方式，例如，基于对调查问卷、评估文件、ISO9000证书、分析检测结果和该供应商的历史经验进行评估是否可行？

kk444555: EEA检查官一般不倾向于“纸面审计”，因为这样无法提供与现场评估相同水平的结果，但可以接受将其作为基于风险策略的一部分。如果可以获得近期检查信息，且过去的现场审计都令人满意时，就可以采用这种方法。书面审计不能代替对原料药供应商进行的现场审计，但可以作为生产商审计计划的中间和临时措施。The EEA ...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 23:08

EU_GMP

问答 如果活性物质供应商已接受过EEA成员国的审计，且其GMP证书在有效期内，我是否还需要对其进行审计？

kk444555: 生产许可持有人有时会对其检查义务范围产生疑惑，但是不管怎样，如果供应商具有检查报告，或由EEA互认伙伴及其它互认国家药监局签发的GMP证书，均可以给生产许可持有人提供有用的信息。然而，这并不能完全代替GMP指南第5.25部分提出的生产许可持有人的法定义务和要求，但生产许可持有人可以将上述检查结果与其...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 23:07

EU_GMP

问答 How can GMP compliance for active-substance manufacturers be demonstrated?

kk444555: 法令2001/83/EC及修订内容（法令2001/82/EC兽药）指出生产许可持有人有义务仅使用根据GMP指南生产的活性物质作为起始物料。因此，法律将该责任赋予了使用该活性物质的生产许可持有人，而并没有要求对活性物质生产商进行强制的定期检查。为了指导原料药生产商如何建立GMP合规性，本网站已公布了指...

赞同0 反对 0 人感谢 0 评论 1 回复

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...

赞同0 反对 0 人感谢 0 评论 1 回复

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...

赞同0 反对 0 人感谢 0 评论 1 回复

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...

赞同0 反对 0 人感谢 0 评论 1 回复

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...

赞同0 反对 0 人感谢 0 评论 1 回复

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...

赞同0 反对 0 人感谢 0 评论 1 回复

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 ...

赞同0 反对 0 人感谢 0 评论 1 回复

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...

赞同0 反对 0 人感谢 0 评论 1 回复

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...

赞同0 反对 0 人感谢 0 评论 1 回复

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...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 22:53

EMA

问答 在临床药品（IMP）开发阶段整个过程中是否要对HBEL进行重新评估？

kk444555: Health-Based Exposure Limits should be established based on all available data, and particularly as the knowledge base for IMPs is continually evolvin...

赞同0 反对 0 人感谢 0 评论 1 回复