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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
- 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
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Rathore, A.S., Bansal, A., Hans, J. (2012). Knowledge Management and Process Monitoring of Pharmaceutical Processes in the Quality by Design Paradigm. In: Mandenius, CF., Titchener-Hooker, N. (eds) Measurement, Monitoring, Modelling and Control of Bioprocesses. Advances in Biochemical Engineering/Biotechnology, vol 132. Springer, Berlin, Heidelberg. https://doi.org/10.1007/10_2012_172
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