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

-  Scaleup

-  Establishment of process conditions for each unit operation.
-  Implementation of manufacturing refinements, if required.
-  Standardization of manufacturing process

-  Production

-  Transfer and monitoring of manufacturing process to commercial batches product