Knowledge Management and Process Monitoring of Pharmaceutical Processes in the Quality by Design Paradigm

被引：5

作者：

Rathore, Anurag S. ^{[1
]}

Bansal, Anshuman ^{[2
]}

Hans, Jaspinder ^{[2
]}

机构：

[1] Indian Inst Technol, Dept Chem Engn, New Delhi 110016, India

[2] IIT Delhi, TBIU, Unit 7, Simplyfeye Softwares P Ltd, New Delhi 110016, India

来源：

MEASUREMENT, MONITORING, MODELLING AND CONTROL OF BIOPROCESSES | 2013年 / 132卷

关键词：

Process monitoring; Quality by design; Knowledge management; CELL-CULTURE; PREDICTION;

D O I：

10.1007/10_2012_172

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

Pharmaceutical processes are complex and highly variable in nature. The complexity and variability associated with these processes result in inconsistent and sometimes unpredictable process outcomes. To deal with the complexity and understand the causes of variability in these processes, in-depth knowledge and thorough understanding of the process and the various factors affecting the process performance become critical. This makes knowledge management and process monitoring an indispensable part of the process improvement efforts for any pharmaceutical organization.

引用

页码：217 / 247

页数：31