HEL/Skytech jointly organised a seminar recently in Hyderabad and Bangalore. Discussions were held on the topic ‘Using DOE in Combination with Parallel Reactor Platforms – QbD perspective as per US FDA regulation’. The seminars in Hyderabad and Bangalore were attended by process engineers, chemists and managers from pharmaceutical companies.
Dr Jasbir Singh, Chief Executive Officer, HEL Group presented various case studies and data with respect to DOE and parallel reactor systems for different processes like crystallisation and hydrogenation and how it helped in enhancing the product yield during the development stages in R&D.
The importance of QbD regulation from process optimisation and risk management was presented by D Malviya, Country Manager, along with the benefits obtained by the innovator company with QbD duly implemented and how generics companies will be required to implement QbD from regulatory point of view.
EP News Bureau – Mumbai