How can a design space beverified at commercial scale for biological products? - 分享质量人的知识和经验

登录

1: 关注

991: 浏览

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

EMA

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

如何在生物产品的商业规模上验证设计空间？

好问题 0 评论收藏举报

查看全部 1 个回答

kk444555 一阶会员用户来自于: 广东省深圳市
2023-10-17 23:00

Principles laid down for chemical productsare applicable to biological products. In addition, verification studies shouldprovide evidence that the quality attributes of the product are comparableprior to and after the change. This could include a proposal for modular setsof tests and acceptance criteria to be deployed, taking into account the natureof the change and its associated risk.

为化学产品制定的原则适用于生物产品。此外，验证研究应提供证据证明产品的质量属性在变更前后具有可比性。这可能包括对采用的模块化检测和验收标准的提议，同时考虑到变更的性质及其相关风险。

赞同 0 0评论

关于作者

: 风清飞扬 二阶会员
这家伙很懒，还没有设置简介

149: 回答

84: 文章

475: 问题

问题动态

发布时间: 2023-10-17 23:00

更新时间: 2023-10-17 23:00

关注人数: 1 人关注

相关问题

What is the purpose of design spaceverification at commercial scale?: 998 浏览 1 关注 1 回答 0 评论

How should manufacturers use the HBELs?: 853 浏览 1 关注 1 回答 0 评论

can we onlycompare the key performances?: 1162 浏览 1 关注 1 回答 0 评论

How can I obtain the impurities listed in a monograph?: 999 浏览 1 关注 1 回答 0 评论

can theelectrical safety and electromagnetic compatibility test beexempted?: 1030 浏览 1 关注 1 回答 0 评论

How does FDA recommend data integrity problems be addressed?: 1003 浏览 1 关注 1 回答 0 评论

How is a design space initiallydeveloped and verified at commercial scale?: 952 浏览 1 关注 1 回答 0 评论

How to determine the naming rules for softwareversion?: 1062 浏览 1 关注 1 回答 0 评论

How can GMP compliance for active-substance manufacturers be demonstrated?: 797 浏览 1 关注 1 回答 0 评论

How do the new requirements affect importers of medicinal products?: 934 浏览 1 关注 1 回答 0 评论

推荐内容

问清洁验证完成之后，共用设施里的设备中更换产品时是否需要进行分析检测？: 901 浏览 1 关注 1 回答 0 评论

问 How should design spaceverification protocol be addressed in the submission?: 887 浏览 1 关注 1 回答 0 评论

问 What is the purpose of design spaceverification at commercial scale?: 998 浏览 1 关注 1 回答 0 评论

问 How should design spaceverification approach be addressed in the pharmaceutical quality system?: 993 浏览 1 关注 1 回答 0 评论

问 Why would a design space beverified during the product lifecycle?: 1023 浏览 1 关注 1 回答 0 评论

问基于问卷调查、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?: 940 浏览 1 关注 1 回答 0 评论

问如果原料药生产的发酵工艺中使用了蛋白胨（例如动物和植物来源），是否需要放在相关注册资料中？: 907 浏览 1 关注 1 回答 0 评论

问在同一设施中生产不同物种的兽药时要考虑什么？: 965 浏览 1 关注 1 回答 0 评论

问生产基地、厂房和房间的哪些变更可以由公司质量保证体系 (GMP) 覆盖？: 897 浏览 1 关注 1 回答 0 评论

问 Is the use of LD50 to determine Health-Based Exposure Limits for drug products acceptable?: 967 浏览 1 关注 1 回答 0 评论

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