The National Institute of Pharmaceutical Education & Research (NIPER), Punjab is conducting a two-week training program from September 11-21, 2017 on the topic “Pharmaceutical Quality by Design- A risk-based approach”.
This training program is sponsored by Ministry of External Affairs, Government of India under Indian Technical and Economic Cooperation (ITEC) and Special Commonwealth Assistance for Africa Program (SCAAP). The participants in the training session were from 12 different countries. All the participants were from drug regulatory, pharmacist and quality control background.
NIPER is conducting such training programs from past 18 years. The participants are from countries like Afghanistan, Cuba, Egypt, Ethiopia, Kenya, Malawi, Mauritius, Mozambique, Peru, South Africa, Vietnam and Zimbabwe.
Prof. P.V. Bharatam, Dean NIPER, welcomed the participants and expressed his views on quality by design in Pharmaceuticals. Prof. Raghuram Rao Akkinepally, Director-NIPER said, “QbD is becoming a widely used term in Pharmaceutical Development. He also mentioned about the changes that have occurred over the years in terms of quality. Earlier quality was related to the finished product but now it has been imbibed into the whole manufacturing process till the finished product. Though earlier it used to be practised in the other industries but not in the pharma industry.”
Prof. Raghuram Rao also mentioned QbD can be considered as holistic, system-based approach to the design, development and delivery of any pharmaceutical product to the consumer. These concepts facilitate in building quality into pharmaceuticals from development through manufacturing and using sound scientific knowledge to demonstrate and assure safety, quality and efficacy of a pharmaceutical product throughout its entire lifecycle. QbD is important for all products including generics products.”
Many other participants like Prof. Sanjay Jachak, Course coordinator and Dr. Dinesh Dua, CEO and Director, Nectar Life-sciences and Vice-chairman, Pharmaexcil shared their views regarding the QbD importance in Pharmaceutical industry.