风清飞扬的主页 - 分享质量人的知识和经验

登录

风清飞扬二阶会员

这家伙还没有留下自我介绍

保密

关注: 177 | 粉丝: 71 | 积分: 536478 | 威望: 3 | 访问: 46302

风清飞扬在 2023-10-17 23:09 发起了提问 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...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-17 23:08 发起了提问 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 ...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-17 23:08 发起了提问 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...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-17 23:07 发起了提问 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...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-17 23:01 发起了提问 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...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-17 23:00 发起了提问 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...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-17 23:00 发起了提问 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...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-17 22:59 发起了提问 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...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-17 22:58 发起了提问 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...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-17 22:57 发起了提问 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 ...; 关注问题 1  0  0 评论

个人成就

获得 160 次赞同

被 71 人关注了

关注了 177 人

技术支持 WeCenter © 2024 粤ICP备2023143277号-1