Emergency and temporary changes in GMP: how to move fast without losing control

Real operations produce situations where waiting for the full change process is not acceptable: a failed critical component, a safety issue, a supply interruption that would cause a shortage. Regulators do not forbid speed. They require that speed does not remove the assessment. A good procedure defines the emergency and temporary routes in advance so that the decision is made calmly, before the emergency.

What counts as an emergency

Define it narrowly and in writing: an immediate risk to patient safety, product quality, people or the environment, or loss of a critical function where delay would cause that risk. 'The batch is late' and 'the supplier changed at short notice' are business pressures, not emergencies, and should use the standard route with a shortened timeline.

What the emergency route must contain

1. A named Quality role who can authorise the emergency route verbally or electronically, and records who, when and why.
2. Opening the change record at the time of authorisation, or the same working day, so the change is on the register from the start.
3. A minimum risk check before acting: what could this affect, and is a safe interim measure available.
4. The full impact assessment and approval completed within a defined number of days, typically five to ten working days.
5. Qualification, testing or verification of the emergency measure, or a documented rationale and a plan to complete it.
6. Review of the emergency in the next quality meeting, with a decision to keep, modify or reverse.

Temporary changes

A temporary change is a deliberate, time-limited alteration with a defined reversal, used for example during a shortage, a trial or a repair. It goes through the normal change process with three extra fields: an end date, the reversal plan and the owner who will confirm reversal or request conversion to a permanent change. A temporary change that passes its end date becomes an open finding, so the system should send reminders and escalate automatically.

Keeping the exception exceptional

• Report the number of emergency and temporary changes, and the number overdue, in the monthly quality metrics and in management review.
• Investigate any department that uses the emergency route more than occasionally; it usually signals a planning or maintenance problem, not a series of emergencies.
• Treat an emergency change with no completed assessment after the defined period as a deviation.
• Do not allow the same temporary change to be renewed more than once without a QA decision to make it permanent.

The standard sequence that the emergency route is the exception to, along with the approval logic by class, is described in the complete guide to GMP change control and in the guide on approval, implementation and verification.