The Good Automation Machinery Practices (GAMP) introduced by the US FDA recently is likely to bring the much needed emphasize on the technological improvisation and quality parameters in the pharmaceutical machinery and allied engineering sector, says Dr. P.G. Shrotriya, technical director, M.J. Biopharm Pvt Ltd and an expert on GMP.
With the increasing advancements in the information and automation technology, the US FDA in its guideline book has now stressed two new requirements, the Good Automation Machinery Practices (GAMP) and Good Distribution Practices (GDP), which are already in practice in the US and other developed countries, he added while speaking at the seminar organised by the Indian Pharmaceutical Machinery Manufacturers Association (IPMMA) titled International Regulatory Compliance — Role of Pharma Machinery. The seminar was held today in Mumbai.
According to him GAMP and GDP are already being practiced by US and Europe-based pharma companies. In the coming years as the role of Indian pharmaceutical industry would become more critical, GAMP and GDP would become a compliance requirement for the Indian companies too, he asserted.
With its high engineering and designing capabilities, Indian pharma machinery manufacturers were second to none, he said. “If every manufacturer gives thrust on quality and innovation, India could scale a class above in the eyes of foreign machinery manufacturers. This would in turn help Indian machinery manufacturers to grab prestigious manufacturing contracts from foreign companies,” said Dr. Shrotriya.
“India, with its quality and less expensive infrastructure could make machines for MNCs. We are already exporting machinery to unregulated and semi regulated markets in Africa and Asia, and regulated markets in Europe,” said Bhavna Shah, President, IPMMA.