上海cmc培訓(xùn)overviewofregulatoryframeworkandcmcrequirementsintheus-資料下載頁
2025-01-16 14:31本頁面
【正文】 m e n tD e v e l o p m e n tP r e A p p r o v a lI n s p e c t i o nUS Activities to Commercial Pharmaceutical PoskaCMCOverview 062810 34 Journey to Desired State CURRENT STATE TRANSITION DESIRED STATE Guidances Quality Detection Quality By Quality Type Paradigm CFR 210/211 SUPACs Reactive Proactive Corrective Action Continuous Improvement Innovation Measureable Specs Meaningful Specs Attribute Testing Design 21st Century Risk Based Initiatives Risk based regulatory scrutiny is associated with the level of scientific understanding PoskaCMCOverview 062810 35 Where are the “opportunities”? ? Know your process, keep improving it, share info – Understand your moleculeBCS – Define and identify “critical” ? Process controls and parameters – Make information part of public domain – Think globally! ? Use new technologies when justified to lower manufacturing risks. – Will need to consider overall impact ? Can they be cost effective? ? Consider PAT correlations when meaningful product attributes have been established PoskaCMCOverview 062810 36 Challenges we face… ? Nonharmonized stability requirements ? Dynamic countryspecific regulatory and pendial anization and requirements ? Business need for prompt registrations ? Desire for specific packaging configurations PoskaCMCOverview 062810 37 … and… ? New technology ? Shortened product development cycle to contain and recoup costs ? Expectation for greater understanding of product and processes for both industry and regulators ? Controlled headcount allowances PoskaCMCOverview 062810 38 Closing Thoughts ? Excessive and differing regulatory requirements, standards and guidances will not guarantee improved product quality. – Cross disciplinary collaboration (within and between partners) will lead to reduced variation and improved consistency.
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