Buyer guide · 22 pages

OTC Topical Manufacturing Guide

Inside

1. Right formula. Right fill. Your quality unit decides.
2. One cream batch, component to carton.
3. Drug, cosmetic or both?
4. The OTC route and the rules that follow.
5. Components wait until they are released.
6. Dispense to the approved master record.
7. Phases, heat and time, as your process defines.
8. Clean equipment, identified on the record.
9. Fill, check weights, clear the line.
10. Drug Facts, issued and reconciled.
11. Test the batch, keep pending visible.
12. Stability supports the date on the crimp.
13. Review the record, then decide.
14. Contract work: write down who decides.