Pharmaceutical Engineering Strategy for Quality Informatics on the IDEF0 Business Process Model
Pharmaceutical Engineering Strategy for Quality Informatics on the IDEF0 Business Process Model
复制标题
IDEF0 业务流程模型上的质量信息学制药工程策略
DOI：
10.1007/s12247-012-9140-z
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发表时间：
2012
影响因子：
2.6
通讯作者：
Y. Naka
中科院分区：
文献类型：
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作者：
Hirofumi Kawai;H. Seki;T. Fuchino;Y. Naka
IntroductionIntroduction复杂的现代制药业务活动努力实现精益发展所需的质量水平，通过应用质量设计（QbD）approach.MethodsTo工程师合适的信息流质量发展通过这种方法，用集成定义语言（IDEF 0）的0类方法编写的业务流程模型通过分析公司实际活动，为生物制药开发活动创建。结果和讨论该模型包括产品质量设计、配方开发、工艺工程等工程活动，和生产.在QbD方法中，活动分为五个阶段。信息流，触发计划做检查行动（PDCA）周期超出的阶段（垂直PDCA），以及在同一阶段（水平PDCA）被defined.ConclusionWith该模型作为参考，它成为可能设计一个广泛的信息共享系统应用QbD的方法所需的一系列功能的活动。
IntroductionIntricate modern pharmaceutical business activities strive to achieve lean development for the desired quality level by applying the quality by design (QbD) approach.MethodsTo engineer suitable information flows for quality development by this approach, a business process model written in the type 0 method of integrated definition language (IDEF0) was created for biopharmaceuticals development activities by analyzing actual company activities.Results and DiscussionThe model comprises engineering activities of product quality design, recipe development, process engineering, and production. In the QbD approach, the activities are hierarchized into five stages. Information flows that trigger plan–do–check–action (PDCA) cycles beyond the stages (vertical PDCA) as well as those in the same stage (horizontal PDCA) are defined.ConclusionWith the model as reference, it becomes possible to design an extensive information sharing system applying the QbD approach to the activities necessary for a series of functions.
DOI：
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发表时间：
2008
期刊：
影响因子：
--
作者：
T.Fuchino;Y.Shimada;M.Miyazawa and Y.Naka
通讯作者：
M.Miyazawa and Y.Naka
具有独立保护层意识的流程设计的业务流程模型
DOI：
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发表时间：
2011
期刊：
影响因子：
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作者：
A. Meslem;F. Yamazaki;Y. Maruyama;T. Fuchino
通讯作者：
T. Fuchino