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Identity, Purity, Strength, Composition: Testing under the Dietary Supplement GMPs
The manufacturing of dietary supplements has faced increased testing requirements under GMPS, but there are numerous resources available to help sort out the right testing specs and protocols.
June 3, 2014
2 Min Read
Report Summary
Testing requirements under dietary supplement good manufacturing practices (GMPs) are forcing manufacturers to verify the authenticity of components through testing. Identity, purity, strength and composition must be verified by testing at various stages throughout the manufacturing process, as well as for the finished product. The regulation puts the burden on firms to decide on the specs and testing methods that will best ensure quality, but resources are available to help sort through the testing confusion.
Editor's Take
The dietary supplement GMPs (good manufacturing practices) have presented many changes and challenges to manufacturers and other parties held responsible under the regulation. Some old ways of doing business with suppliers is being forced to change, and testing requirements have increased. One of the testing challenges is the GMP final rule does not spell out exactly what to test, nor when and how, except to say the firm must create specifications for components at various stages of manufacturing and testing of identity, purity, strength and composition must involve "appropriate" tests that are "scientifically valid." This open-ended regulation can leave many supplement companies bewildered about how to comply, but there are numerous resources from industry, government and third-party organizations that can help figure out what specs to set and how to test for them.
Takeaways for Your Business
Manufacturers and brand owners have the biggest responsibility for testing under GMPs.
The regulation requires testing at the beginning and end of manufacturing, as well as in-process.
Testing requirements focus on ensuring authenticity and preventing contamination and adulteration.
NSF International offers a comprehensive range of global services to meet the needs of todays dietary supplement industry. Its role is to ensure finished product and ingredient safety, giving both manufacturer and end user peace of mind through GMP compliance, accredited certification programs, auditing, testing and training.
NSF offers also an assortment of GMP related training throughout the USA.
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