Abbreviations
- QbD
= Quality by Design
- AQbD
= Analytical Quality by Design
- QbT
= Quality by Testing
- MODR
= Method Operable Design Region
- OOS
= Out-of-Specification OOT=Out-of-Trend
- ICH
= International Conference of Harmonization PAT = Process Analytical Technology
- FDA
= Food and Drug Administration
- cGMP
= current Good Manufacturing Process
- LCA
= Life Cycle Assessment
- TMU
= Target Measure Uncertainty
- QTPP
= Quality Target Product Profile
- ATP
= Analytical Target Profile
- CQA
= Critical Quality Attributes
- RA
= Risk Assessment
- DoE
= Design of Experiment