A deviation is a departure from an approved instruction or established standard — a batch record step not followed, an equipment parameter outside its range, a room used before it was released, or a sampling plan applied incorrectly. Deviations are usually classified as minor, major or critical according to their potential impact on product quality and patient safety.
Some deviations are planned: a temporary, pre-approved change to a procedure for a defined batch or period. Most are unplanned and must be reported promptly, contained, investigated and closed through a controlled workflow.
Why it matters in GMP
Under US cGMP, 21 CFR 211.192 requires that any unexplained discrepancy or failure of a batch to meet its specifications is thoroughly investigated and documented. EU GMP and WHO GMP have equivalent expectations. A batch that has an open, unassessed deviation should not be released, and inspectors look closely at whether investigations reach a real root cause.
- Record what happened, when, where and who was involved — while it is still fresh.
- Assess the impact on the affected batch, and on other batches that could share the cause.
- Decide whether corrective or preventive action is needed, and track it to closure.
How Swat iQua Suite handles it
Swat iQua Suite runs each deviation through review, approval and a decision, with four distinct people for initiator, reviewer, approver and decision-taker. An e-signature on approval can be required per site. Deviations are also raised automatically from the rest of the system — an out-of-limit critical process parameter in the eBMR, an environmental monitoring excursion, a sterile failure or a raw data review finding — and a linked CAPA moves with the deviation’s approval. Open deviations and CAPAs block the batch release checklist.