上海cmc培訓(xùn)qualitybydesignapproachtoformulationandprocessdevelopmentcasestudiesfornd-資料下載頁(yè)
2025-10-10 08:32本頁(yè)面
【正文】 r flowability? ? Excipients – What properties of the excipients can affect manufacturing and product performance? Question Based Review and QbD (Continued) ? Formulation – How was the formulation developed and optimized? – Was DoE methodology utilized to determine the critical formulation factors? ? Manufacturing Process – What is the relationship between the properties of the formulation and the optimal manufacturing process? – How are the critical process parameters identified and how are they controlled? ? Quality of Generic Drugs – Approved generic drugs meet high quality standards and are equivalent to their reference products – ANDA rejections are weighted equally to ANDA approval in OGD staff evaluations – Public recognize the OGD’s contribution to product quality – OGD encourages industry to implement QbD 2021 OGD CMC Strategic Goals Lawrence Yu, “Strategic Planning and Question Based Review”, FDA/GPhA QbD Workshop on ANDAs, May 2021 Risk Assessment Example Vaithiyalingram SR, “QbD IR Example: Process Development”, FDA/GPhA QbD Workshop on ANDA, May 2021. CPP and Control Strategy Example (Tabletting) Vaithiyalingram SR, “QbD IR Example: Process Development”, FDA/GPhA QbD Workshop on ANDA, May 2021. Input Criticality Control Strategy Ribbon density Critical PAR: Granule PSD Demonstrated Not Critical PAR: 250 – 500 181。m Granule uniformity Demonstrated Not Critical PAR: 4% RSD Press Geometry Not Critical Fixed Tooling Geometry Not Critical Fixed Feeder Speed Not Critical PAR: 1018 rpm Feeder Fill Depth Not Critical PAR: 1520 mm PreCompression Force Demonstrated Not Critical PAR: Kn Controlled based on Ribbon Density Compression Force Critical PAR: Kn Controlled based on Ribbon Density Ejection Force Potentially Critical Fixed: kN Press Speed Demonstrated Not Critical PAR: 10007000 TPM ? More and more panies are applying QbD principle to more and more products ? Tool and technologies required for QbD are continuously being developed and improving ? QbD is not just about tool and technologies, it is also about culture and philosophy. ? The concepts of QbD, Design Space and PAT are inherently amp。 fundamentally linked. ? Successful implementation of QbD requires – Management support and mitment – A crossfunctional collaboration and a mixture of skills and efforts from various areas of expertise – Working together with the regulators Concluding Remarks
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