GMP Supplier Qualification Appears More Viable Route Than Testing
This article was originally published in The Tan Sheet
While FDA allows supplement manufacturers to use "full testing" of ingredients as an alternative to the supplier qualification process, qualifying still appears to be the most viable and economical approach to GMP compliance
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US manufacturers losing ingredient supplies from China may need to qualify more suppliers, potentially requiring tests of all lots, says EAS Consulting. Contract and other manufacturers also should identify alternative sources for materials they receive from China and prepare for shortages from other countries.
Dietary supplement ingredient suppliers should approach standardizing information in their certificates of analysis as an investment that will pay off in business growth, say industry stakeholders who wrote a CofA guideline
How to qualify ingredient suppliers remains a crucial question for firms seeking to comply with dietary supplement good manufacturing practices