MISSOULA, MONTANA -- Contract manufacturer, Nutritional Laboratories International (NLI), expects to make a seamless transition when the FDA's "Proposed Rule for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Dietary Ingredients or Dietary Supplements" is finally implemented.
In essence, the CGMP Rule holds manufacturers responsible for providing consumers with accurately labeled and unadulterated supplements. It also sets requirements for physical plant construction, establishing quality control procedures, testing of ingredients, maintaining records, and handling consumer complaints.
Jerale Smith, NLI Director of Quality Assurance, said, “I’m pleased that the guidelines are finally coming to fruition. This will even the playing field. The quality that NLI has always offered will now be required of all manufacturers.” Smith can speak with such confidence because her company already meets and exceeds proposed CGMPs.
NLI has provided CGMP-quality, turn-key contract manufacturing services to the dietary supplement and pharmaceutical industries since 1997. In the 6 years since the company’s inception, NLI has built a reputation for excellence by assisting long-standing product marketers in their efforts to stay in the forefront of new and impending regulations in the dietary supplement and pharmaceutical industries. Customer satisfaction has resulted in a solid customer base and continual growth. In 2002, to accommodate expanding growth, the capsule and tablet specialist moved into a 50,000 square-foot custom-designed, FDA-registered facility.
NLI has literally built quality assurance into the new facility’s manufacturing process design. The layout makes for segregated processing, which minimizes errors and increases production controls. Additional segregation and inspection points mean increased data collection and analysis opportunities such as Statistical Process Control (SPC). SPC confirms the repeatability of processing and is a key component of NLI’s sophisticated Quality Assurance system. The increased square footage has also allowed NLI to expand its extensive CGMP-compliant laboratory services for ingredients and finished products, which include analytical, microbial, disintegration and dissolution testing, and stability and shelf life studies.
Smith noted that few manufacturers in the dietary supplement industry utilize such sophisticated quality control tools. Additionally, not all companies have in-house laboratories, and even fewer companies have the wealth of knowledge that NLI scientists bring to the company. “Our lab has been working with natural ingredients since the company was founded. We understand the complexities of natural ingredients and have developed analytical methods to better understand their activity,” explained Smith. When FDA guidelines are finalized, NLI’s in-house laboratories will prove even more advantageous. Data gathered and analyzed in-house and/or validated by third-party laboratories will streamline the testing process.
The events of September 11th  have brought food and drug supply safety issues to the forefront. In June 2002, President Bush signed into law the Bioterrorism Act, which provides measures for protecting the safety and security of the food and drug supply against adulteration. When asked what steps NLI would need to take in order to comply with this Act, Smith assured, “Aside from registering, which takes place in October, we’re already in compliance. That’s because our operations run under established protocols modeled after the FDA’s CGMP requirements for pharmaceuticals. Consumer expectations of quality and safety are high---and so are NLI’s.”
To schedule a tour of NLI’s CGMP-quality facility, please call (406) 273-5493. Ask for Ned Becker, Vice President of Sales, Marketing & Business Development, or visit www.nutritionallabs.com for a full listing of our services and capabilities.