NIPER Conducts Course on Pharma QbD

New Delhi, November 17, 2018: S.A.S. NAGAR: A two-week intensive training programme on “Pharmaceutical Quality by Design (QbD): A Risk Based Approach” was organized by National Institute of Pharmaceutical Education & Research (NIPER), S.A.S. Nagar, Punjab from September 4-14, 2018. The training programme, sponsored by the Indian Technical Economic Cooperation (ITEC), Ministry of External Affairs, Government of India (GoI), is being conducted by NIPER since last 20 years. A total of 20 participants from 10 countries, viz. Algeria, Bangladesh, Cuba, Egypt, Ethiopia, Kenya, Mauritius, Malawi, Sri Lanka and Sudan, with background of drug regulatory, pharmacist and quality control, attended the course. The resource persons from the pharmaceutical industry, academia and regulatory agencies presented lectures and participated in the deliberations. About 8 sessions were held on hands-on experience training on different analytical instruments. A visit to Regional Drug Testing Laboratory and two industry visits were also conducted.

The inaugural session was held with lamp lighting and Saraswati Vandana. Prof P.V. Bharatam, Dean, NIPER, welcomed the participants and encouraged them to take maximum benefit of the course. Giving course introduction to guests and participants, Dr Sanjay Jachak, Professor & In-Charge, Department of Natural Products, NIPER and course coordinator, highlighted, “By employing QbD, the manufacturers can significantly reduce their losses.” He added, “The regulators will have greater confidence in quality of products they are being asked to approve and will be able to reduce the intensity of their regulatory oversight.” He also mentioned about the various guidelines of QbD like good scientific development (Q8) in combination with Quality Risk Management (QRM) (Q9), product quality systems (Q10) and development & manufacture of drug substances (Q11).

In his speech, Prof (Dr) Raghuram Rao Akkinepally, Director of NIPER, expressed that QbD was becoming an important and widely used term in pharmaceutical development. He remarked, “The market and outreach of the medicine has become easier due to quality as the world markets are accepting Indian products without any hesitation.” He added, “After ICH guidelines, the pharmaceutical market has shrunk and one can easily supply products to any country provided the company complies with certain standards which are globally acceptable.” He concluded, “India is the pharmacy of the world because it is the third largest manufacturer of generics. In addition to producing quality medicine, India is also participating in capacity building through training courses like ITEC.”

N.R. Munjal, Managing Director, IndSwift Ltd, the chief guest of the function, praised NIPER for its capability in producing skilled manpower which is acceptable in the pharma industry. Stating that the Indian Pharmacopoeia is maintaining the standard of publishing monographs of new drugs, he appealed to ITEC participants to promote Indian monographs in their countries also. “This is because Indian monographs are at par with United States Pharmacopoeia & British Pharmacopoeia and in that case should be acceptable worldwide”. Dr Naresh Sharma, President of IPA (Delhi Branch) was also one of the speakers of the session.

Finally, the session ended with vote of thanks proposed by Prof Sanjay Jachak.