FDA Guidance: Know Your Bulks and Excipients Suppliers
FDA guidance on supplier qualification for bulk drug substances and excipients, including testing expectations, USP/NF compliance, and sourcing from registered facilities.
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Choose this to reduce API sourcing risk with regulator-backed supplier checks.
Recommends sourcing API from FDA-registered facilities
Emphasizes valid certificates of analysis
Highlights USP or NF monograph compliance
Pro tip: For API procurement, require a certificate of analysis and supplier test method details before ordering.
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