论质量源于设计(QbD)在工艺改进过程中的应用—以LP片包衣为例讲义.docx

I 摘 要 研究背景：在 FDA 的要求下，QbD（Quality by Design，质量源于设计）已成为制 药行业提高药品质量的发展方向。 研究目的：用 QbD 方法对现有产品 LP 片的包衣工艺进行技术改进，解决工 艺问题。同时借鉴国外先进经验，结合国内现状，梳理分析现行政策下 QbD 的 具体做法，并就如何实施提出意见和建议。 研究方法：使用 DOE（Design of Experiment）方法在包衣工艺改进过程中进行 QbD 实施。通过正交实验设计来找出影响包衣工艺的关键因素以及因素间关系，再用全析 因设计对部分参数进行小范围的优化。国情特点和国内外相关经验，结合本次 QbD 实 施结果，总结归纳 QbD 实施的难点和可行性。 研究结果和结论：实施 QbD 虽然前期投入成本较高，但是其可以降低生产成本， 提高企业的产品质量和市场竞争力。 关键词：工艺改进；QbD 实施；实验设计；药品质量 II QbD Application to Process Improvement -A Case of Coating Process for LP Tablet Abstract Background: Under the FDAs requirements, the QbD (Quality by Design) has become the development trend for pharmaceutical industry development to improve the product quality. Objective: QbD methods were used in the improvement of the coating process for the legend LP tables to solve the process problem. And the recommendations and the proposals were put forward by scrutinizing the practical pathway under the current policies with the advanced experiences in foreign countries in combination with the current conditions in China. Methods: The QbD method was employed in the improvement of the coating process through DOE (design of experiment) method. The critical factors that have impacts on coating process and the interrelations between these factors were screened out through orthogonal design, and some parameters were optimized with full factorial design. Based on the results of the QbD implementation, the difficulties and the feasibility for the implementation of QbD were summarized with the consideration of the domestic conditions and the relevant abroad experiences. Results and Conclusion: the upfront cost for the implementation of QbD was higher, but the implementation of QbD could reduce the manufacturing cost and improve the product quality and market competiveness. Keywords: Process improvement; QbD implementation; Design of Experiment; Pharmaceutical quality III 目 录  HYPERLINK \l _TOC_250015 第 1 章 引言 1  HYPERLINK \l _TOC_250014 1.1 研究背景 1  HYPERLINK \l _TOC_25001