Foothill Ranch, CA
cGMP QC testing of the finished dosage form against its specification per ICH Q6A, from an FDA-registered, DEA-licensed lab. One Certificate of Analysis covers identity, assay, related substances, dissolution, and uniformity, run by scientists who follow up.
| Attribute | Method | Result | Status |
|---|---|---|---|
| Identification | HPLC / IR | Conforms | PASS |
| Assay | HPLC | 99.4% LC | PASS |
| Related substances | HPLC | 0.18% total | PASS |
| Dissolution | USP <711> | Q met at 30 min | PASS |
| Uniformity of units | USP <905> | AV 4.1 | PASS |
| Water content | USP <921> | 2.6% | PASS |
Finished product testing is the QC panel run on a manufactured lot of drug product to confirm it meets its specification, the agreed set of tests, methods, and acceptance criteria defined under ICH Q6A. The results are documented on a cGMP Certificate of Analysis that supports lot disposition. It is the last analytical checkpoint before a batch moves forward.
A finished product specification is a set of attributes, each with a compendial or validated method and an acceptance criterion. For a typical solid oral dose, ACTA runs the panel below and reports every attribute against its spec on one Certificate of Analysis.
For nonsterile dosage forms, microbial limits by USP <61> and <62> are available through ACTA's microbiology group.
Most finished product work at ACTA is solid oral, tablets and capsules, immediate and extended release. Oral liquids, suspensions, and semisolid dosage forms are handled with the same compendial approach, including the fill and volume checks those forms require.
ACTA tests finished products using compendial procedures, customer provided methods, or in-house developed methodologies, referenced to USP, BP, EP, JP, and FCC. Assay and related substances methods are stability indicating, so the same panel supports both lot disposition and stability studies.
Every finished product project ends in a cGMP Certificate of Analysis. It lists each specification attribute, the method used, the result, and the acceptance criterion, with a clear pass or fail, so your quality unit has the documentation it needs to make a lot disposition decision. Whether that Certificate of Analysis supports an internal decision or a submission is yours to direct.
New client. Small batch. One dosage form. Start here.
Test the incoming material and the finished product with the same lab, the same methods, and one point of contact. No handoff between vendors.
The national labs bid on large programs and pass on the rest. A single lot of finished product is exactly the work ACTA takes on.
You reach a person, not a queue. Quotes come back fast, and someone owns your project from sample receipt to a signed Certificate of Analysis.
Identity and compendial testing of incoming actives and excipients, so one lab covers the material and the finished dose.
View serviceICH Q1A storage and pull-point testing that reuses the same stability indicating assay to set shelf life.
View serviceHPLC potency and impurity profiling per USP <621>, the analytical core of the finished product panel.
View serviceFinished product data has to survive an audit. ACTA runs to cGMP and holds the registrations that regulated clients require of a testing partner.
