Short answer: Treat China sourcing as a traceability and import-control project: identify the actual manufacturer, qualify the material and confirm destination-market requirements before shipment.
What to establish
Ask whether the contracting party is the manufacturer, exporter, distributor or coordinator. Map manufacturing, testing, storage and export handoffs. Request the manufacturer’s relevant quality documentation and a lot-linked specification and COA rather than relying on broad country-of-origin claims.
What to verify
For a pre-purchase sample, record the sender, seal, sample ID and method plan. Independent testing can reduce an evidence gap but does not prove that a later shipped lot is identical. Agree in advance on discrepancy handling and change notification.
Decision and next step
Confirm import and customs requirements with the destination’s qualified importer. FDA notes that US API import is subject to applicable requirements; this guide does not promise admissibility, specific lead times or a universal regulatory route.
Practical request
Use the points above to request a defined product, sample or lot record. Ask the document issuer to explain any discrepancy; do not infer regulatory suitability from a catalog listing.
Related guides
Primary sources
- ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- FDA, Importing Active Pharmaceutical Ingredients
Educational procurement guidance. Confirm the current rules for the exact material, market and intended use before purchase or use.
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