By Mark A. Desorbo
MISSOULA, Mont.—A contract manufacturer of dietary supplements says implementing the same current good manufacturing practices (cGMPs) required for pharmaceutical aseptic processing will be a “seamless transition” once the proposal is mandated by the Food and Drug Administration.
“These regulations will help the consumer and make a level playing field,” says Jerale Smith, director of quality assurance at Nutritional Laboratories International (NLI), which specializes in tablets and capsules.
Ned Becker, vice president of sales and marketing, adds that audits of the NLI facility by pharmaceutical manufacturers have placed the nutraceutical maker “well ahead of the curve. We're already moving toward the pharmaceutical arena with products that require prescriptions, like prenatal vitamins.” Becker adds,”We have long anticipated tighter regulations from FDA.”
Previously, dietary supplements have not been subject to mandatory standards for manufacturing or labeling. Congress, however, gave the FDA the authority to develop and implement cGMPs as part of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
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Now, under the FDA's proposal, the $19 billion industry would be required to “evaluate the identity, purity, quality, strength and composition of their dietary ingredients and supplements. The draft outlines requirements for designing and constructing physical plants, establishing quality control procedures, and testing manufactured dietary ingredients and supplements. It also includes proposed requirements for maintaining records and for handling consumer complaints related to cGMPs.
Smith and Becker say NLI is already complying with federal aseptic processing regulations. NLI moved in to a 50,000 square-foot, FDA-registered facility last year to not only accommodate expanding growth but to minimize cross-contamination and enhance cleaning protocols outlined in its standard operating procedures (SOPs).
“Moving into the new facility was very helpful. It was laid out using materials that are easily cleaned, like cinderblock walls with heavy-duty epoxy paint,” Smith says, noting manufacturing floors are also epoxy-coated. “That alone is wonderful. You can just take a high-pressure washer and hose them down. Before, we had to wipe everything down by hand.”
More than half of the facility, she estimates, is designated clean space that is not yet classified. The manufacturing areas, however, are positively pressurized, and personnel working in those environments wear bunny suits and lab coats—consistent with ISO Class 6 to ISO Class 8 cleanrooms.
“Everyone who comes in contact with the products are wearing gloves,” Smith adds. Manufacturing areas, where encapsulating, tableting and blending occur, undergo a regular environmental monitoring program for analytical and microbial testing.
“We are using a swabbing technique that allows us to identify zones to prevent cross-contamination,” Smith says.
NLI also employs statistical process control (SPC), which serves as a checks-and-balance system for tablet and capsule size and weight. A series of lights alerts operators—red indicates a fluctuation, yellow signifies a change trend, and green means the process is functioning normally.
“You have normal variation in all processes, and SPC allows you to see something out of the norm,” Smith say. “It's a visual thing for the operators so they can intervene before the process gets out of control.”