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Pharmaceutical Manufacturing Magazine April 2005,

Nutri Granulations: Validation using the Team Concept.

At Nutri Granulations, a team of 20 runs an entire drug-licensed facility — and loves it.

NUTRI GRANULATIONS,
A DIVISION OF E.T. HORN COMPANY

Every 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.

“We get together and give everybody something to think about,” says plant production manager Mike Garcia. “We toss something out there and say, ‘Think about it and come back to us later with your ideas.’ 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.”

This is what teamwork is about at Nutri Granulations, a division of the chemical and raw materials distributor E.T. Horn Company (both based in La Mirada, Calif.). Garcia and the facility’s 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—the plant has a running string of nearly 700 days without a “lost-time work injury”

FROM FOOD TO PHARMA

Alan 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. “We began by starting every Wednesday with what we call our weekly training sessions,” 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. “We jointly put together all of the validation packages and the documentation that were not required when we were operating under our old food license,” Huffington says. “As 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.”

Two particular events during the validation process illustrate the cohesion and commitment of the entire Nutri Granulations staff. The first was an unforeseen hitch when production at the facility had ramped up to the degree that warehouse space had become cramped. The group knew that it somehow had to reconfigure or expand its warehouse capacity without disrupting normal activities or slowing down the ongoing validation process.

During one Wednesday meeting, the entire staff went to the warehouse and sat down on the floor to brainstorm how it could be accomplished. They talked about things like material movement, and the need for separating quarantined and released materials. In time, the group agreed that they had to lease another warehouse nearby for released materials. Within six weeks, a new finished goods warehouse had been inspected and qualified, and the team had reconfigured the entire warehousing system while keeping true to the requirements of first-in, first-out design.

Another hurdle the team cleared was devising a cleaning validation process worthy of a drug-licensed facility.

CULTURE IS CRITICAL

None of these efforts would have worked without a culture of trust. The company encourages workers to “buddy up” with colleagues who have completely different functionalities. This paves the way for a production operator, for instance, to fill in for a QA specialist if needed. Even management jumps in. It’s not uncommon to see Huffington, the regulatory expert, on the production line making batches, or Garcia, the production manager, helping the third shift at 2 a.m.

Huffington, Garcia and VP and general manager Kurt Schneider keep their doors open at all times should anyone in the facility want some one-on-one time. And the openness and transparency extend to suppliers and customers, who are both free to visit and roam the plant (staying outside the yellow lines, of course), and to talk with employees.

Employees have strong motivation to perform. “The line item in our budget that has to do with reward and recognition is one of the largest lines in our entire operating budget,” says Schneider.