|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharma-product-design-technology-commercial-manufacturing/
课程评论：没有评论
## **药剂产品设计、技术与商业化生产课程总结** 本课程旨在全面介绍药剂产品从设计到商业化生产的整个流程。 **核心内容涵盖：** * **产品设计与质量源于设计 (QbD)：** 遵循ICH Q8指南，深入理解如何设计药剂产品，并有效应用质量源于设计理念，从源头上保障产品质量。 * **技术转移：** 重点关注分析技术和生产工艺技术在生产单位间的转移过程，确保技术顺利过渡。 * **工艺验证：** 在技术转移完成后，对首批商业化生产批次进行详细研究，满足工艺验证要求。 * **强效分子生产：** 课程特别设置了关于强效分子生产的专题讲座，强调在此类特殊产品的生产过程中应采取的额外保护措施。 * **稳定性研究：** 在工艺验证之后，详细介绍稳定性研究的执行，包括长期稳定性研究的年度持续进行，以评估产品在不同储存条件下的质量变化。 **课程价值：** 本课程为所有医药行业从业者提供了一个宝贵的学习平台，帮助他们系统性地掌握从产品设计、技术转移、工艺验证到最终商业化生产及后期稳定性研究的全过程知识。
This course will take you to understand about how product is designed, product transfer & validation aspects before commercialisation. After commercialisation further it will focus on how stability study is performed.First of all, we need to learn about product development as per the ICH guideline - ICH Q8. This will explain us about how to design the pharmaceutical products and also how quality by design concept to be followed. After this, main step is about technology transfer in the pharmaceuticals. This technology transfer will focus on transfer of analytial technology as well as manufacturing process technology in the manufacturing unit. Once technology is transferred, the first commerical batches manufactured should be studied in detailed as per the process validation requirements. Furthermore, it is important to note that, there is special care to be taken in case of manufacturing of potent molecules. So, a separate lecture on manufacturing of potent molecules is available in this course. This is still not enough for pharmaceutical products. After process validation, the process validation batches should be subjected for stability study. Furthermore, long term stability study will be continuted for every year. Overall this training session will be very much helpful for all pharmaceutical professionals for learning from design the product to commercialisation.
