A recent article in the Chicago Tribune claims that 1 in 4 dietary supplement manufacturers companies by the agency have received an FDA warning letter. They also claim that FDA found GMP violations in two-thirds the 200 supplement firms’ facilities inspected this year.
Why is GMP compliance so important? Just ask the more than 200 people who were poisoned by selenium after taking a multivitamin dietary supplements. The products contained over 40,000 micrograms of selenium per serving instead of 200 called for in the specifications. A well run GMP manufacturing facility would have tested their incoming dietary ingredients for purity and would have used a master manufacturing record to control the amount of selenium added to the final product. Following GMP requirements prevents the errors and oversights that result in adulterated product.
Improving the quality of products manufactured has several benefits to it, consumer trust will increase for a brand and result in more sales; and batches will be much more consistent, thus allowing manufacturers to have a better handle on material/production costs. Establishing and enforcing specifications allows for manufacturers to ensure that their products contain the highest quality active ingredients as well.
Be sure to check out our solution for Dietary Supplement manufacturers, InstantGMP™ MES, for more information.