Change control and deviation management formalised
Ergopharm has formalised its change control and deviation management procedures, establishing that no validated process, system or document changes without prior assessment, and that no unplanned event closes without investigation.
The two procedures are mirror images. Change control governs what is done deliberately: a proposal is assessed for impact on product quality, on validation status and on the commitments made to partners, then approved, implemented and verified as effective. Deviation management governs what happens anyway: an event is recorded, contained, investigated for root cause, and closed with corrective and preventive action where the cause justifies it.
“"Operator error" is where an investigation should get interesting, not where it should stop.”
The failure mode both are written to prevent is the same — a change made quietly because it seemed minor, or a deviation closed as 'operator error' because that requires no further thought. Neither procedure permits a conclusion that names a person as the root cause without asking what in the system made the error possible.
Effectiveness checks are scheduled rather than optional: an action that has not been shown to work has not been completed.
Key facts
- Change control
- Impact assessment before implementation; effectiveness verified
- Deviations
- Recorded, contained, investigated to root cause
- Not accepted
- "Operator error" as a terminal root cause
- Closure
- Scheduled effectiveness check before an action is closed
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.