NPA’s raw ingredient testing program in China was set up in 2007 to provide US supplement manufacturers with quality assurances prior to shipment of product.
“Instead of relying either on tests provided by China or post-shipment tests, US manufacturers can test the quality of Chinese raw materials prior to shipment. The testing of ingredients from China-based companies is coordinated between the NPA headquarters in Washington and the NPA-China office in Beijing,” said the group.
How the testing works
The testing program allows Chinese suppliers interested in exporting to the US to contract with NPA for ingredient sample testing. The supplier provides NPA-China’s Beijing office with a representative samples for a lot or batch, which is then blinded and sent to US Pharmacopeia (USP)-China.
USP undertakes the testing in its Shanghai location, and results are provided to NPA within 10-14 working days. This process does not convey USP Verification for the ingredient, cautions NPA.
The trade association then notifies the supplier of the results, which it also posts on its website to be viewed by NPA members.
NPA said that members who order materials that have been tested through the program can submit samples for a re-test free of charge after receiving them, to confirm the integrity of the material.
The latest addition to the NPA testing program ingredient database is chondroitin from the Chinese supplier Shandong Zhongyuan Greentech.
The sample tested had been manufactured in July 15 2008, and carried a lot/batch number of M0807015.
The test results revealed that the ingredient met requirements for: Clarity and color of solution; specific rotation (-27.4˚); microbial enumeration; pH (7.4); loss on drying (6.5 percent); residue on ignition (25.6 percent); chloride (not more than 0.50 percent); heavy metals (not more than 0.002 percent); electrophoretic purity; limit of protein (not more than 6.0 percent); and content of chondroitin sulfate sodium (90.9 percent).
However, the ingredient sample did not meet requirements for sulfate content. The specified sulfate acceptance limit was not more than 0.24 percent, but test results for the ingredient recorded ‘more than 0.24 percent’.
The full results are available to NPA members here.
"You can get quality ingredients from China. I don't think there's any doubt about that," Daniel Fabricant, NPA vice president of scientific and regulatory affairs, told NutraIngredients-USA in 2007, when the group launched its Chinese testing program.
"By testing raw materials in China, we're adding another layer of consumer protection to a process that has delivered good health products to Americans for generations," said David Seckman, NPA executive director and CEO.
NPA says this process could reduce transit times and costs, as well as favor greater traceability and documentation of ingredients used in the supply chain.
NPA’s ingredient testing program, along with its good manufacturing practices (GMP) certification program, were featured in the US Department of Health and Human Services’ July 2008 Interagency Working Group Report to the President on Import Safety as positive private sector initiatives to improve product quality, safety and transparency. To access the report, click here.