Bench scale experiments as per planning and Identification of critical parameters
Co-ordination with QC for analytical support / development and Prepare sample as per required quality
Optimization of process w.r.t. identified critical parameters and Impurities characterization and synthesis.
Understanding the parameters responsible for impurities.
Process validation by reproducing min. three consecutive batches.
Experimental observations and data compilation
Demo batches to PD
To check quality plan/ Plant SOP and Use test of RM’s
Data compilation and time to time update of KL/ PP plant trials