Starting point
The references describe retrospective qualification of a tablet press for a pharmaceutical client to current GMP standard and support of FAT and SAT plus on-site qualification of extruders for a pharma supplier.
Vendors and clients remain unnamed: we do not invent brands. For QA this still means complete IQ/OQ/PQ documentation, review and completion report following GAMP-aligned practice.
Approach
cube one created qualification documents, executed tests and owned the completion report in the validation manager role.
Tablet press (retrospective)
- Qualification documents created to current GMP standard.
- Retrospective IQ/OQ/PQ under risk-based approach.
- Completion report and release by validation manager.
Equipment and facility qualification.
Extruders (FAT/SAT through on-site)
- Plant documentation from FAT and SAT supported.
- On-site qualification including test cases and review.
- Qualification completion report owned.
Result
Both programmes closed
- Press retrospectively qualified and GxP released.
- Extruders supported from FAT/SAT through on-site qualification.
- Client and exact model details remain confidential.
Audit readiness
- Complete qualification file without invented vendor names.
- IQ/OQ/PQ protocols reviewed and closed.
- Related: NanoDrop One.
No customer names, no invented vendors.