Product and process development embodies all the studies that give rise to high quality formulations and robust manufacturing processes.
Benchmarking, QbD-oriented approaches, utilizing scientific knowledge and risk management, identify process parameters and unit operations that affect critical quality attributes (CQAs) of the drug product.
- Formulation Studies
- Screening studies applying the statistical approach of Design of Experiments (DoE)
- Optimization studies-Standardization of optimal formulation levels
- Selection of optimum formula
- Confirmatory studies
- Process Development
- Identification of key process parameters and determination of the interactions between operating parameters and compositional constituents
- Setting of the normal operating design space
- Identification of dedicated equipment
- Establishment of process conditions for each unit operation.
- Implementation of manufacturing refinements, if required.
- Standardization of manufacturing process
- Transfer and monitoring of manufacturing process to commercial batches product