A two-week workshop on 'Pharmaceuticals quality by design: A risk based approach' was concluded at National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar on 4th December, 2014. Total 16 participants from countries like Armenia, Sudan, Myanmar, Kenya, Egypt, Guayana, Uzbekisthan, Mongolia, Jordan, Zimbabwe and Cuba have participated in the programme.
This programme was sponsored by ministry of external affairs, Government. of India under Indian Technical and Economic Cooperation (ITEC) and Special Commonwealth Assistance for Africa Program (SCAAP) for the personnel with background of drug regulatory, pharmacist and quality control, attended this course.
Prof. K. K. Bhutani, Director, NIPER expressed that the theme of the course, Quality by Design (QbD) is a recent paradigm in pharmaceutical arena and is becoming important in pharmaceutical product development. QbD can be considered as holistic, system-based approach to the design, development and delivery of any pharmaceutical product to the consumer. QbD is closely aligned with many concepts found in ICH guidelines, Q8, Q9, Q10 and Q11. 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.
Further Prof. Sanjay M. Jachak, course coordinator informed that QbD is important for all products including generics and biotech products. Analytical testing is important and plays a key role in QbD. The goal of QbD is to bring medicines to patients in a more reliable way. Manufacturers will see production improvements with significantly reduced batch failures, stock-outs etc. Various eminent speakers from Pharmaceutical Industry such as Ranbaxy, Panacea, IndSwift Laboratories, Nectar Life Sciences etc. and Academia (Panjab University and NIPER) deliberated during this two weeks programme.