Knowledge Management and Process Monitoring of Pharmaceutical Processes in the Quality by Design Paradigm - Measurement, Monitoring, Modelling, and Control of Bioprocesses - page 217

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

Anurag S. Rathore, Anshuman Bansal and Jaspinder Hans

Abstract Pharmaceutical processes are complex and highly variable in nature.
The complexity and variability associated with these processes result in incon-
sistent and sometimes unpredictable process outcomes. To deal with the com-
plexity 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 man-
agement and process monitoring an indispensable part of the process improvement
efforts for any pharmaceutical organization.

Keywords Process monitoring Quality by design Knowledge management

Abbreviations

BDS Bulk Drug Substance

BPR Batch production record

CAPA Corrective And Preventive Action

cGMP Current good manufacturing practices

CFR Code of Federal Regulations

CPP Critical process parameters

CQA Critical quality attributes

DO Dissolved oxygen

ERP Enterprise resource planning

FDA Food and Drug Administration

HCD Host cell DNA

A. S. Rathore ( )

Department of Chemical Engineering, Indian Institute of Technology,
New Delhi 110016, India
e-mail: [e-mail]
A. Bansal J. Hans
Simplyfeye Softwares (P) Ltd, TBIU, Unit 7, Synergy Building, IIT Delhi, Hauz Khas,
New Delhi 110016, India
e-mail: [e-mail]
J. Hans
e-mail: [e-mail]

&