Jai Mehta has spent more than 25 years in pharmaceutical industry. His areas of expertise include product development, quality systems, plant design, build-out and commissioning, regulatory affairs and validation of facility, utilities, equipment and processes. Currently, he is chair of the Nutraceutical Focus Group of the American Association of Pharmaceutical Scientists (AAPS). Mehta has developed new business for bulk and formulation drug manufacturers, clinical research labs and the packaging industry. During his consulting career, he has audited and assisted API, dosage forms, and clinical research firms in the U.S. as well as numerous other countries. Mehta has experience in filing European and U.S. drug and biologics applications and drug master files for excipients and packaging components. Mehta has a Bachelor’s degree in pharmacy and a Master’s degree in medicinal chemistry from Bombay University and a Master’s degree in biopharmaceutics from the University of Illinois. He is a registered pharmacist in the states of Arizona and Illinois.
Mehta is an avid follower of Health E-Insights.
Health E-Insights: As chair of the nutraceutical focus group of the AAPS, what are your responsibilities and what do you hope to accomplish?
Mr. Mehta: The chair of APPS Nutraceutical Focus Group (NFG) learns the ropes (so to speak), as chair elect for two years and then has a two-year term as the chair. I have this responsibility for 2010-2012. The chair heads the steering committee, which is appointed by invitation of previous and current chairs. My responsibilities and my accomplishment goals include developing program proposals for symposia and workshops for annual meetings, developing and conducting webinars, maintaining the focus group web page, and growing community and membership outreach programs such as issue newsletters, educational emails and leadership transition development, including selection of the chair elect and bringing new blood to the steering committee.
Health E-Insights: From a pharma standpoint, what significant trends do you see in the supplement industry and will the two work more closely together in the future?
Mr. Mehta: DSHEA and Good Manufacturing Practice (cGMP) for dietary supplements, while not the final cGMP regulations, are not as exacting as those for drugs, but they do add significant quality controls and testing requirements. These new cGMP requirements bring the supplement industry closer to drug and pharma manufacturing standards. AAPS is mainly a pharma industry trade association and the NFG provides the bridge between the two industries. I personally am working to bring in representatives from nutraceutical industry trade associations to join our steering committee and develop collaborative symposia and workshop programs. The pharma industry has much to offer the supplement marketplace in terms of cGMP experience and we hope to work closely with this rapidly growing industry in the future to share our hands-on knowledge.
Health E-Insights: How does your company work with supplement manufacturers?
Mr. Mehta: For a cGMP gap analysis audit, we send a questionnaire, which is customized by each operation and each quality system. This questionnaire can be filled-out in draft form and appropriate staff and data and documentation kept ready for a plant audit visit. The actual site visit could be for two to five days, depending on the size of the facility and the depth of audit requested. The findings are discussed at the end of each day. A wrap-up meeting is conducted at the end of the site visit when all major findings would be discussed. An audit report with our discoveries and recommendations would be issued shortly after the visit. In many instances we assist with the outcome management of the gap analysis results. JM Pharma also supports dietary supplement manufacturers with achieving certifications such as the USP program.
Health E-Insights: Do you feel JM Pharma is positioned for success?
Mr. Mehta: JM Pharma has been in existence since 1996. When I co-founded and built Red River Pharma, a dietary supplement development manufacturing company in Louisiana, in 2002, we temporarily exited the consulting business. Three years later we again started providing consulting services. We have adapted our services and expertise areas with the ever-increasing regulatory standards in the drug and supplement industry in the U.S. and globally. We stay current with the FDA and International Conference on Harmonisation (ICH) drug regulations and guidance by closely monitoring and participating in the evolution process of new standards. I have been a member of the drug substance working group of the Product Quality Research Initiative/Institute introduced by the FDA and AAPS. I have given numerous seminars in the cGMP quality systems arena over the last 20 years, addressing state-of-the-art industry advances and regulatory standards. JM Pharma, with its proven track record stays focused on new developments and is well-positioned for regulatory changes and manufacturing consulting opportunities in the pharma and nutraceutical arenas.
Health E-Insights: What’s the worst business advice you ever received?
Mr. Mehta: To buy used equipment to set up a new manufacturing facility.