Visakhapatnam: The Andhra University will have a joint workshop with US Food and Drug Administration on “Current Good Manufacturing Practices” in Visakhapatnam on February 23 and 24.
Briefing the media on Tuesday, Vice-Chancellor of Andhra University Prof P.V.G.D. Prasad Reddy said a team from the most prestigious US Drug Regulatory Body, FDA, headed by Dr Carmelo Rosa would be the keynote speakers dealing with Pharma regulatory issues and on the basic and advanced GMP topics.
The workshop is the first of its kind between USFDA and any other University outside the US. Around 300 top Pharma industry personnel, academicians, Indian drug regulatory members, scholars and students of Pharmacy are expected to attend the workshop.
It will focus on Pharma industry regulatory issues during manufacture and testing which are vital for the export of drugs to the US and observations that are likely to be made by the USFDA inspection team would be of great concern to the Indian Pharma industry. The GMP practice topics being covered during these two days will be immensely useful to the students and faculty in enriching their knowledge, the V-C said.
The students once graduated would be confident to deal with all the manufacturing operations in the Indian Pharma industry. Hence it is supposed to be a win-win situation both for academia and the Pharma industry and reduces the chances of deviations from regulatory compliance as prescribed by the USFDA and make their job easy, Prof Reddy said.
