Business continuity measures sustain supply
Ergopharm has maintained production through a period of severely disrupted international logistics, using shift separation, increased inventory buffers and dual sourcing of critical materials.
Continuity in a regulated plant is constrained by what cannot be relaxed. Cleanroom occupancy limits, gowning requirements and release procedures are not adjustable in an emergency, so continuity has to be found elsewhere — in how shifts are arranged, how much material is held, and how many qualified sources exist for the things without which the line stops.
“You cannot relax a gowning procedure in a crisis. So continuity has to come from somewhere else.”
Shifts were separated so that a case in one team could not remove the whole production capability, with no overlap in changing rooms or canteens. Inventory of active substances, primary packaging components and critical consumables was raised well above normal cover, and second sources were qualified for items where a single supplier had been acceptable in calmer conditions.
No quality requirement was waived. Where a supplier could not be audited in person, remote assessment was used with the limitations recorded, and the assessment repeated on site when travel resumed.
Key facts
- Shifts
- Separated with no shared changing rooms or canteens
- Inventory
- Critical materials held well above normal cover
- Sourcing
- Second sources qualified for single-source items
- Not waived
- Quality requirements; remote assessments recorded with limitations