This document discusses deviation management in the pharmaceutical industry. It defines deviations as departures from approved procedures that can be planned or unplanned. Proper deviation management is important for product quality assurance, continuous improvement, regulatory compliance, and reducing rejections and complaints. Deviations should be reported in writing, investigated, classified based on risk and impact, approved or rejected, trended over time, and addressed to prevent future occurrences. Common inspection findings include a lack of proper deviation handling, documentation, investigation, trending and corrective actions.

1. By
Washington Dengu (BPharm, BCom)
Protecting Your Right to Quality Medicines and
Medical Devices

2. Definition.
• Departure from approved procedure or process or the
result thereof.
• Can be planned (seen before it happens) or unplanned
(realised after it has happened already).
• Unplanned deviations also termed incidents.
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3. Why bother about sound deviation
management?
a. Product Quality Assurance
b. Source of continuous improvement.
c. Good business sense. Less rejections/recalls/complaints.
d. Regulatory requirement
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4. Guideline (WHO TRS986 Annex2)
16.3 Deviation from instructions or procedures should be
avoided as far as possible. If deviations occur, they should be
in accordance with an approved procedure. The authorization
of the deviation should be approved in writing by a
designated person, with the involvement of the QC
department, when appropriate.
 Also sections 16.20; 17.3d, f, m & s; 9.14e; 15.27i; 15.30h;
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5. Pre-requisites for successful
deviation management.
1. Validated processes.
2. Consultatively written procedures.
3. Integrated organisation in harmony
4. Understanding the idea and significance behind the effort, to
product quality & to the business.
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6. When faced with a deviation
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7. Deviation reporting (in writing)
Vs
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8. QA/departmental investigations
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9. Risk & impact assessment
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10. Classification of deviations
• Based on risk and impact to product quality.
• Critical, major and minor deviations.
• Level of investigation depends on the classification.
• All must be recorded and numbered.
• A bound register (logbook) preferable.
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11. Approval
• Based on outcome of risk/impact assessment.
• QA decision.
• Implementation ONLY after approval for planned deviations.
• Batch disposition. (proceed to next stage or reject).
• TIMELY.
• Repetitive deviations
• Change control
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12. Post implementation,
deviations must be;
• All deviations must be closed before batch release.
• Justification for not closing timely
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13. Monitor Critical and Major deviations
beyond batch shelf life.
• Retention samples
• Stability monitoring
• Post Market surveillance
• Be Proactive
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14. Annual trending
• How many planned deviations
• How many incidents
• How many in production, QC, QA, Engineering etc
• How many critical/majors/minor
• How many repetitive deviations
• How many are still open/ closed in time
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15. Common Inspection observations
• No deviation register/ log book
• Approvals not based on risk/impact assessment
• SOP in place but not being actioned.
• SOP not being trained to all relevant people
• Suspicious Zero-deviations for years
• Deviations not being investigated
• Lack of trending & the resultant recommendations
• No way of dealing with repeated deviations

17. Protecting Your Right to Quality Medicines and Medical Devices

18. Group 1
• During the manufacture of 300kg batch size of Digoxin 0.25ug tablets by
World Pharma Ltd, the following was observed at blending stage. After wet
granulation, drying & particle size reduction, the operators added the
lubricants and blended the mixture. They obtained a yield of 302kg against
acceptable range of 296kg-299kg. Immediately after offloading they
proceeded for compression.
• Question. Comment. How would you have handled the situation, as
the QA manager of World Pharma Ltd, clearly indicating the problem,
what could be the root cause, the risk and impact etc.
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19. Group 2
• During the manufacture of a 100L batch of Ciprofloxacillin suspension, the volume
100L is obtained by topping up the mixture to the 100L mark with Purified Water
BP. The operator overshoot the mark. He then took a clean stainless steel bucket
and scooped off the excess. More careful now, he slowly made upto the exact mark
of 100L. The production supervisor immediately came, checked the 100L mark, the
reconciliation and released the bulk suspension for packing.
• Question. Comment. How would you have handled the situation, as the QA
manager of World Pharma Ltd, clearly indicating the problem, the risk and
impact, preventive action etc.
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20. Group 3.
• During an internal audit of the Quality assurance department, the inspectors
found that no single deviation had been recorded in the last 12months. The
deviation register was an uncontrolled counter book. 3 market complaints
had been recorded in the 12 months. One batch had been reprocessed
successfully.
• Question. Discuss. How would you have handled the situation if you
were the internal auditor?
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