DEVIATION (NOTES)

In pharma, a deviation is any departure from an approved instruction, established procedure, validated process, specification, or expected condition during manufacturing, packaging, testing, storage, or distribution. Deviations matter because they can affect product quality, patient safety, data integrity, and regulatory compliance. A mature deviation system is a key part of the Pharmaceutical Quality System (PQS).

Common types of deviations

• Process deviations: wrong parameter (time, temperature, speed), incorrect addition order, missing step, hold-time exceedance.
• Equipment/utility deviations: breakdowns, calibration overdue, HVAC differential pressure excursions, water system excursions.
• Material deviations: damaged containers, wrong label/status, mix-ups, OOS results, incorrect dispensing.
• Documentation deviations: missing entries, wrong entries, late recording, uncontrolled forms, printing errors.
• Environmental deviations: EM alerts/action exceedance, temperature/humidity excursions in storage or transport.

Typical deviation lifecycle (GDP/GMP expectation)

1. Detection and reporting: deviations should be reported immediately (including near-misses).
2. Initial impact assessment: determine if product is potentially affected; apply containment actions (stop activity, segregate material, quarantine batch).
3. Investigation: collect evidence (BMR/BPR, equipment logs, alarms, raw data), identify root cause using tools like 5-Why, Ishikawa, or fault tree.
4. Risk assessment: assess patient/product impact using QRM (severity, occurrence, detectability) and define batch disposition options (release, rework, reprocess, reject).
5. CAPA: corrective action fixes the issue; preventive action reduces recurrence (procedure redesign, engineering controls, training improvements).
6. Effectiveness check and closure: verify CAPA worked (trend improvement, no recurrence over defined cycles).

Regulatory expectations and good practices

Deviations must be documented, traceable, and closed on time, with QA oversight. Repeated deviations indicate weak control and should trigger trending and management review. For critical deviations, regulators expect documented batch impact, possible field action assessment, and timely communication where required.

Common inspection findings include superficial root cause (“human error”), repeated recurrence, weak impact assessment, and closing deviations without effectiveness evidence.