Regulary Ases Pru Develmen ICH Press Q, Q, Q资料.ppt

Regulary Ases Pru Develmen ICH Press Q, Q, Q资料.ppt

  1. 1、本文档共38页,可阅读全部内容。
  2. 2、原创力文档(book118)网站文档一经付费(服务费),不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
  3. 3、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。如您付费,意味着您自己接受本站规则且自行承担风险,本站不退款、不进行额外附加服务;查看《如何避免下载的几个坑》。如果您已付费下载过本站文档,您可以点击 这里二次下载
  4. 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“版权申诉”(推荐),也可以打举报电话:400-050-0827(电话支持时间:9:00-18:30)。
查看更多
Regulary Ases Pru Develmen ICH Press Q, Q, Q资料

World Health Organization * * World Health Organization * * World Health Organization * * World Health Organization * * World Health Organization * * Pharmaceutical Development To design a quality product and its manufacturing process to deliver the intended performance of the product To provide scientific understanding to support the establishment of design, specifications and manufacturing Product development studies form a basis of quality risk management Pharmaceutical Development Quality cannot be tested in the product; it should be built in by design Design space proposed by applicant is subject to regulatory assessment and working within the space is not a change Movement out of design space is considered to be a change and requires post-approval change process Pharmaceutical Development Critical aspect of drug substances, excipients, container closure system and manufacturing process should be determined Opportunities exist to develop more flexible regulatory approach, e.g. Risk-based regulatory decisions Process improvement within the approved design space without further regulatory review Reduction in post-approval submissions Real time quality control, leading to a reduction of end product testing Q8: Pharmaceutical Development Paths Current Understanding at ICH API Dosage Forms For small large molecules Traditional (basic) pharmaceutical development Enhanced (QbD) In-depth understanding of process Design Space Process Validation Quality by Design Summary The quality of drug substances and drug products is defined by their design, development, in-process controls, process validation, and by specifications applied to them throughout the development and manufacture With the use of mathematics and statistical approaches, the DOE will prove theoretical critical control points in a process Optimum yield, reduce variation, build robustness in the product and process requires Design of Experiment Quality by Design Summary (cont’d) Optimization of product

文档评论(0)

seunk + 关注
实名认证
内容提供者

该用户很懒,什么也没介绍

1亿VIP精品文档

相关文档