If the Indian organizations implement Quality by Design (QbD ) into the processes, it will not only help the domestic market but also will help to meet international standards leading to overall improvement of products, according to Dr Line Lundsberg, senior consultant , Quality by Design , Lundsberg Consulting , UK.
This top down approach will be of competitive advantage to the Indian pharma industry which already has a high understanding of the regulatory issues ,best process understanding and has world class research facilities. This new organisational approach will enable the industry to capitilize on its potentials in the global arena, she added.
With completion and regulations getting tougher day by day and validation and submission being top priorities of all the pharma organization, QbD is one of the best alternatives to carry out simple, efficient and affordable processes. This technology is a real eye-opener to the industry and should be implemented in a phased manner and from level to level , Dr Line Lundsberg said.
Today the US and Europe looks at Indian pharma companies for affordable as well as quality products. This can only happen when the process understanding & risk management are addressed, she said.
Three -day interactive workshops on QbD was held in Mumbai and Hyderabad from from March 8 to 12, to benefit the pharma companies in API and formulations on the analytical areas. Apart from Dr Line Lundsberg, Dhaval Trivedi of Intas Biopharma also took part in the sessions.
QbD was a concept developed by the pharmaceutical and biopharmaceutical industry and health authorities in the US, Europe and Japan with the patient in focus to develop and commercialize products based on a scientific and risk- based foundation. QbD is a lifecycle approach and makes development and manufacturing potentially more efficient with high financial impact on costs.
This workshop focused on areas such as business cases for QbD, how should organization look to using ICH Q8,Q9,Q10 and Q11, practical understanding of GQAs,CPPs, material attributes, design space and control strategy, PAT (Process Analytical Technology), DOE (Design of Experiments), application of QbD for making qualification and validation easier, science based and risk based verifications with practical examples and verifications.
The interaction looked at how Qbd would not only reduce the risk assessment but also the right utility of fund and manpower in the evaluation of drugs.
The Conference Director of International Business Conferences (IBC), Ravi Krishnamurthy who took the lead to organize the programme said QbD is not a process which can be done overnight. “Let us begin the phase and look to risk in phases, correct it and move along and one fine day it will be a right QbD in place, and this will make us at par with international standards. We will make it soon”.
The programme was highly appreciated by participants from Torrent Phamra, Lupin Laboratories, Arch Pharma, Divis Labs, Matrix and many more who have decided to implement QBD as a part of their development programmes.