NSF is currently using industry developed GMPs proposed to the FDA as the basis for audits. GMP compliance will be a requirement of the NSF Certification Program.
Manufacturers with quality systems in place should not have to significantly change/expand their current systems or include additional routine testing. A key component of the NSF certification process is to verify a manufacturer's current systems for preventing adulteration, and ensuring the correct identity and traceability of the raw material and finished product.
NSF will compare raw materials and finished products to authenticated reference materials provided by the American Herbal Pharmacopoeia (AHP), The University of Mississippi or other organizations, especially where no compendia or pharmacopial standards exist. NSF is collaborating with AOAC, AHP, the Institute for Nutraceutical Advancement (INA) and other organizations to continue the development of compendial standards.
NSF may use a manufacturer's analytical method(s) while assisting with their validation. Methods may change as additional information becomes available. In such cases, adequate notice will be given prior to the adoption of any new method. Even with an established method in place preference to an individual manufacturer's method may be appropriate where matrix interferences or other problems warrant.
For manufacturers whose process begins with harvesting the plant, NSF recognizes the validity of raw material identification and evaluation using gross plant morphology and organoleptic testing by qualified personnel. NSF also recognizes the validity of qualitative finished product evaluation based on batch records and organoleptic testing. NSF will verify manufacturer's testing by using chromatographic fingerprinting and other techniques on raw materials and finished product. It is important to note that this does not preclude manufacturers from using their own evaluation methods for internal purposes.
NSF will qualitatively evaluate all botanical materials by such methods as: DNA typing, gross morphology, microscopic morphology, chromatographic fingerprinting or any other appropriate methods. In addition, quantitative analyses will be used where quantitative marker claims are made. Quantitative test methods include: HPLC, GC, LC/MS, or any other appropriate methods. Polymerase Chain Reaction (PCR) has shown promise in qualitative analysis of botanicals. Currently, we are developing PCR capabilities and methods.
Key trade associations and NSF International work together as a strategic alliance that will provide the most comprehensive certification program for the dietary supplement industry.
Benefits of the alliance include the ability to:
Maintaining NSF Certification requires continual compliance to the requirements of NSF/ANSI 173-2003. The Certification Program includes annual audits and periodic evaluation of certified products. Companies are required to provide notification to NSF International of any changes or reformulations of their certified products.