AU, USFDA to conduct joint workshop on manufacturing

Visakhapatnam: Andhra University and US Food and Drug Administration (USFDA) will conduct a joint workshop on ‘current good manufacturing practices’ at Andhra University in Visakhapatnam on Feb 23 and 24.
This workshop, said to be first of its kind between USFDA and any other university outside the USA, focuses on pharma industry regulatory issues during manufacturing and testing.These components are vital for export of drugs to the USA and the observations that are likely to be made by the USFDA inspection team would be of great concern to the Indian pharma industry.
A team from the USFDA, headed by Dr Carmelo Rosa, will be the keynote speakers. Their session will deal with pharma regulatory issues and the basic and advanced good manufacturing practice (GMP) topics. About 300 pharma industry top management personnel, academicians, Indian drug regulatory members, scholars, and PG students of pharmacy will attend the workshop.
“The GMP topics, which will be covered during these two days, will be immensely useful to the students and faculty in enriching their knowledge. The students once graduated would be confident to deal with all the manufacturing operations at the Indian pharma industry. Hence it is supposed to be a win-win situation both for academia and the pharma industry. This will help reduce the chances of deviations from regulatory compliance as prescribed by USFDA,” said Andhra University Vice-Chancellor Prof PVGD Prasad Reddy.