Systems Approach to Process Lifecycle Engineering in Pharmaceutical Production

被引：3

作者：

Kawai, Hirofumi ^{[1
]}

Seki, Hiroya ^{[1
]}

Kitajima, Teiji ^{[2
]}

Fuchino, Tetsuo ^{[3
]}

Naka, Yuji ^{[4
]}

机构：

[1] Tokyo Inst Technol, Chem Resources Lab, Midori Ku, Yokohama, Kanagawa 2268503, Japan

[2] Tokyo Univ Agr & Technol, Inst Engn, Koganei, Tokyo 1848588, Japan

[3] Tokyo Inst Technol, Dept Chem Engn, Meguro Ku, Tokyo 1528550, Japan

[4] Techno Management Solut Ltd, Kita Ku, Yokohama, Kanagawa 2220033, Japan

来源：

KAGAKU KOGAKU RONBUNSHU | 2014年 / 40卷 / 03期

关键词：

Pharmaceutical Production Process; Lifecycle Engineering; Activity Model; Quality by Design;

D O I：

10.1252/kakoronbunshu.40.194

中图分类号：

TQ [化学工业];

学科分类号：

0817 ;

摘要：

In pharmaceutical industries, lifecycle management of process improvement by coordinating product design, recipe design, facility development, and production activities is necessary to develop robust and consistent production processes that satisfy requirements for product quality. The business process of pharmaceutical process lifecycle engineering is described in an activity model that defines the stages of plan-do-check-act. On the basis of this model, procedures and a change-management system in lifecycle engineering were developed. The procedures and the system can be continuously improved by the activity model-based systems approach to achieve practicable process lifecycle engineering in pharmaceutical production.

引用

页码：194 / 200

页数：7

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