Quality and documentation
Confidence you can check.
A process you can see, documents you can hold, and a written procedure for the day something goes wrong.
From raw material to release.
Injectable formats are filled aseptically with in-process checks on the line; incoming materials are inspected and tested; packs are serialized. Every product is finished and shipped from the United States.
Sourcing
Raw materials are inspected and tested on arrival, and each one carries a certificate of analysis.
Formulation
Every batch is compounded to a written formula and batch record.
Fill and finish
Injectable formats are filled aseptically, with in-process checks on the line.
Lyophilization
Freeze-drying turns solution into a stable cake, reconstituted only at use.
Testing and release
Analytical testing before release, finished-product testing on request, serialized packs.
What you can hold in your hand.
Every item below is available before or with your first order.
Certificate of analysis
A raw-material certificate of analysis is available for every product.
Finished-product testing
Finished-product testing by an analytical laboratory is available on request and quoted per lot.
Licences
Patient-specific prescriptions are compounded and dispensed by a state-licensed 503A pharmacy; office-use stock is compounded by a registered 503B outsourcing facility. Licence numbers are shared during account review.
Documentation pack
Send your supplier qualification questionnaire with your application and we confirm in writing what we provide before you commit.
Storage, format by format.
Lyophilized vials ship and store cold-chain. Dual-chamber pens stay unmixed until first use, then go in the refrigerator. Topicals, oral formats, mints, gum and chews are shelf-stable.
| Format | Storage and shipping |
|---|---|
| Pens and cartridges | Unmixed until first use, then refrigerated |
| Lyophilized vials | Cold-chain |
| Nasal sprays | Shelf-stable |
| Oral tablets | Shelf-stable |
| Buccal mints | Shelf-stable |
| Functional gum | Shelf-stable |
| Oral pouches | Shelf-stable |
| Professional skincare | Shelf-stable |
| Hair and scalp | Shelf-stable |
| Canine chews | Shelf-stable |
Your quote states the storage and shipping conditions for every product you order.
If something is wrong, here is exactly what happens
- 01Report. Email quality@usagoldstandard.com or tell your account manager. Include the product, lot number and what you observed. We open a case the same business day and give you a case number.
- 02Hold. We ask you to set the affected lot aside. We place the same lot on hold for every account it shipped to.
- 03Investigate. We trace the lot through shipping records and its batch production record, and arrange testing where the issue calls for it.
- 04Decide. We tell you the outcome in writing: release, replace or recall. If we recall, we notify every account that received the lot and arrange return or destruction.
- 05Credit and close. Confirmed defects are replaced or credited. Each case is closed in writing with its root cause and any corrective action.
Quality questions
Can I audit your supply chain?
Audit and documentation requests are handled during account review. Send your supplier qualification requirements up front (questionnaire, documents, site visit) and we confirm in writing what can be provided before you commit. Facility documentation is reviewed after account approval, under NDA; site visits are arranged in writing. After approval, what we can disclose is set out in writing before your first order.
Can I see a certificate of analysis?
Yes. A raw-material certificate of analysis is available for every product. Finished-product testing through a partner laboratory is available on request and quoted per lot.
How do I know the contents match the label?
Only finished-product testing shows what is in a finished lot. It is available through a partner laboratory on request and quoted per lot. Raw-material certificates of analysis are also available for every product.
What about cold chain and stability?
Lyophilized vials ship and store cold-chain. Dual-chamber pens stay unmixed until first use, then go in the refrigerator. Topicals, oral formats, mints, gum and chews are shelf-stable. Your quote states the storage and shipping conditions for every product you order.
What happens with returns and recalls?
We publish a written complaint, quarantine and recall procedure on our Quality page. Report an issue with the lot number and we open a case the same business day.