Biomedical Engineering Reference
In-Depth Information
ICH
International Conference on Harmonisation
LIMS
Laboratory information management system
OOS
Out of specification
PAT
Process analytical technology
PCA
Principal component analysis
PLS
Partial least squares
PQ
Process qualification
QMS
Quality management system
QbD
Quality by design
RVLP
Retrovirus Like Particles
SOP
Standard operating procedure
SPE
Squared prediction error
SCADA
Supervisory control and data acquisition
TPP
Target Product Profile
Contents
1
Process Data and Knowledge Management .....................................................................
218
1.1
Background ...............................................................................................................
218
1.2
D-I-K Hierarchy ......................................................................................................
219
1.3
Understanding Bioprocess Data ...............................................................................
220
1.4
Data Flow Map .........................................................................................................
223
2
Process Monitoring............................................................................................................
225
2.1
Introduction ...............................................................................................................
225
2.2
Tools and Approaches ..............................................................................................
226
3
Knowledge Management and Process Monitoring in the Quality
by Design Paradigm ..........................................................................................................
234
3.1
Quality by Design.....................................................................................................
234
3.2
Knowledge Management and Process Monitoring in the QbD Paradigm .............
237
4
Case Studies.......................................................................................................................
241
4.1
Case Study 1: Root Cause Investigation .................................................................
242
4.2
Case Study 2: Process Improvement .......................................................................
244
4.3
Case Study 3: Real-Time Process Monitoring ........................................................
246
5
Conclusion .........................................................................................................................
246
References................................................................................................................................
246
1 Process Data and Knowledge Management
1.1 Background
Commercial Current good manufacturing practices (cGMP) manufacturing of a
therapeutic product has to continuously go through various checks in terms of
process, people, raw materials, equipment, facility and processing environment.
Availability of and instant access to information regarding past and current records
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