Seminar on International regulatory compliance Role of Pharma Machinery

This seminar was organized on 28th February, 2004 at Hotel Kohinoor continental, Mumbai. The key speaker was Dr.P.G.Shrotriya, the technical director from M/s. M.J.Biopharm private limited.

The major emphasis was on International regulatory requirements for the pharmaceutical industry as per Schedule M, Schedule U, cGMP, US FDA, MCA etc. for the machinery manufacturers. There was a detailed and interactive session on issues like commitment to quality excellence and awareness on cGMP, validation protocols, importance of routine maintenance, in house training and development, quality systems like ISO-9000, standardization and ready availability of spares, post marketing surveillance & services, innovation and continuous improvement of design, design specification of machinery with drawing, IQ,OQ & PQ documentation etc.

There was also a special session on cGMP compliance for the pharma machinery, particularly in the areas of non-sterile and sterile product manufacturing.