Incorporated into the parent company’s Health Sciences Division, NSF Pharmalytica will operate mainly as a contract laboratory focusing on Good Laboratory Practice (GLP) and Good Manufacturing Practises (GMP).
Lori Bestervelt, the company’s senior vice president and chief scientific officer told NutraIngredientsUSA: “NSF Pharamlytica will provide GMP/GLP analytical testing, specializing in extractables and leachables testing, method development and validation, and bioanalysis.”
Other services will include training and research and development . “NSF Pharmalytica offers expert consulting and training in many areas, such as, GLP/GMP compliance, meeting CMC regulatory submission requirements, equipment qualification, process safety and facility audits,” said a company statement.
Bestervelt said: “Combining Pharmalytica’s knowledge in pharmaceutical analytical testing and R&D with NSF International’s existing portfolio of dietary supplement and pharma solutions will help pharmaceutical companies worldwide make informed decisions when developing new products and strategies.”
As the global dietary supplement and pharmaceutical markets continue to grow, demand for such services will also rise, he added.
The company has developed the only American National Standard for Dietary Supplements (NSF/ANSI Standard 173) and certifies dietary supplements to this standard to verify label claims. It also conducts tests to ensure that a product is free of undeclared substances and unacceptable levels of contaminants.
NSF Pharmalytica laboratories are GMP and GLP compliant, are Food and Drug Administration (FDA) registered and inspected and Drug Enforcement Agency (DEA) licensed to handle, store and test Controlled Substances (Schedule I thru V).
Meanwhile, last month NSF International helped create a new voluntary Stability Testing Guideline for supplement manufacturers to ensure they have the necessary data to support expiration dating on product labels.
Current federal regulations and dietary supplement GMPs do not require expiration dating for nutritional supplements. But nearly all dietary supplement products voluntarily use an expiration date on their labels.