We offer structured education programs in pharmaceutical process development, synthetic chemistry, and quality-by-design principles, designed to bridge academic knowledge and industrial practice.

Outline of Course Content

Literature Review and Route selection

•  Details Literature search,
•  Design of different ROS, feasibility studies,
•  ROS selection
•  IP management,
•  Patent infringement analysis,
•  Evaluation of RMC

Process Optimization

• Design of Experiments(DOE) and Quality by Design(QbD)
•  Optimization of reaction conditions,
•  Reagent and Solvent selection
•  Critical process parameters,
•  Identification of impurities and control
•  In-process and intermediate controls

Work-up and Isolation of Product

•  Design simple and practical work-up procedures
•  Safety considerations
•  Consideration of removal of impurities and by-products.

Crystallization and Polymorphism

• Different methods of crystallization
•  Chiral resolution
•  Different solid forms of an API – salts, co-crystals, solvates and hydrates.
•  Amorphous solids
•  Characterization of solid forms
•  Intellectual property and Regulatory issues

Process validation on Lab scale

•  Brainstorming on practical issues for process scale-up
•  Solvent recovery, reuse,
•  TTD preparation

Process scale-up and Tech Transfer

• Consideration of practical issues for process scale-up
•  Process safety, Equipment selection,
•  Cleaning and decontamination procedures.
•  Trial batches,
•  Trouble-shooting
•  Process modification with a change control,
•  Process validation on large scale.
•  Support on DMF submission and approval

Manufacturing

•  Good Manufacturing Practices (GMP)
•  Safety
•  Continual improvement
•  Stability data evaluation
•  Support on DMF submission and approval
•  Address DMF queries from customer/ regulatory authority

Interested please contact e-mail