Nutri Granulations: Validating the Team Concept

PharmaManufacturing.com
At Nutri Granulations, a team of 20 runs an entire drug-licensed facility — and loves it.TEAM OF THE YEAR FINALIST, SMALLER-SCALE PROJECTS:NUTRI GRANULATIONS, A DIVISION OF ET HORN COMPANYEvery Wednesday, management and employees at Nutri Granulations get together for their weekly meeting. The meetings started a few years ago to help with ongoing drug validation efforts. These days, the gatherings tend towards brainstorming and idea sharing as often as they focus on, say, the finer points of 21 CFR 210 and 211. No matter the topic or purpose, the meetings are always informal and open; everyone participates and no one dominates.&ldquoWe get together and give everybody something to think about,&rdquo says plant production manager Mike Garcia. &ldquoWe toss something out there and say, ‘Think about it and come back to us later with your ideas.&rsquo They go back to work and visualize solutions. Then, when we put the issue back on the table again, we have some good ideas about what we need to do.&rdquoThis is what teamwork is about at Nutri Granulations, a division of the chemical and raw materials distributor ET Horn Co. (both based in La Mirada, Calif.) Garcia and the facility&rsquos management have striven to give everyone, from line operators to warehouse personnel, a say in daily operations and project planning.The approach has paid dividends. The company started in 1998 with just four employees, making bulk granulated calcium carbonate for the food industry. It saw more of a market in the pharmaceutical industry, for a USP-grade compound that could be used in antacids and other drug products. So in late 2003, with all 20 employees pitching in, Nutri Granulations undertook a major drug-licensing initiative. By the fall of 2004, it had completed the task, satisfying both state and FDA regulators.Recent operating results at the facility have been impressive to boot:
The plant boasted a 93% uptime in 2004, up from 80% in 2003.
Production throughput increased from 10.3 to 12.4 million pounds last year, while reject/scrap rates dropped from 3.6% to 2.4%.
Worker safety has not been compromised&mdashthe plant has a running string of nearly 700 days without a &ldquolost-time work injury.&rdquo FROM FOOD TO PHARMAAlan Huffington, director of regulatory affairs, and many others at Nutri Granulations had experience with food and pharma regulation, but the validation and documentation process required the efforts of the entire team.&ldquoWe began by starting every Wednesday with what we call our weekly training sessions,&rdquo Huffington says. Their scope has gone way beyond training, with everyone from line operators, heads of quality and production, to VPs, contributing to process and product improvement. &ldquoWe jointly put together all of the validation packages and the documentation that were not required when we were operating under our old food license,&rdquo Huffington says. &ldquoAs a team we went through documenting and validating all of the utilities, equipment, processes and products, until everything that was required by the drug regulations, guidelines and other industry standards had been completed.&rdquo

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