Institutional Injectable Campaign for a Tender Award
Pan-India · Government & Tender Supply
Overview
Campaign manufacture of a non-cytotoxic small-volume injectable against a government tender, with delivery schedule and documentation as the binding constraints.
The challenge
The customer won a tender requiring 2.4 million units across eleven months with liquidated damages for late delivery, and had no internal ampoule capacity for the awarded presentation.
What we did
Capacity was blocked as a committed campaign with fortnightly dispatch tranches rather than one terminal delivery, so early batches cleared release testing while later ones were still filling. Terminal sterilisation with F0 validation gave a defensible SAL, and each tranche shipped with its full release data pack.
Project data
| Units delivered | 2.4 million ampoules |
|---|---|
| Schedule | 11 months, fortnightly tranches |
| On-time delivery | 100% of tranches |
| Sterilisation | Terminal moist heat, F0 validated, SAL 10⁻⁶ |
| Batch failures | None; 2 deviations, both closed with CAPA |
| Documentation | Release data pack per tranche, tender-format CoA |
Standards applied
- WHO-GMP
- Schedule M
- ICH Q1A(R2)
Scope supplied
- General Injectables
- Contract Manufacturing
Related
- General Injectables
- Contract Manufacturing