Any event that represents a departure from documented procedure or standard or specification. Deviations can occur during manufacturing, packing, sampling and testing of finished products and raw materials
Following are the steps for Handling of deviation in pharma industry
1. Reporting deviation
The person identified the incident or event should report the deviation. Record the Deviation in format described as per SOP manually or directly report to QMS software like trackwise, SimplerQMS, Qualio, MasterControl, Q-Pulse and Greenlight Guru.
For reporting deviation following details are required
- Short Description
- Description
- Immediate Actions
- Type
- Department
- Date Occurred
2. Department head approval
After reporting of the deviation, department head approval is required. Department head review the details of deviation and approved for further investigation. if details is not complete department head can revert the process for correction back to the reporter.
3. QA preliminary assessment
- Review and Verify for correctness and relevance of deviation for example what happened, when did happened, department where the deviation occurred, why and how did it happened? who was involved?
- Identity impacted product, material, equipment, process and batches.
- Identity type of deviation like minor, major, critical.
- Confirm the immediate action taken was appropriate and sufficient or not and further any action needed or not.
- Perform the Impact assessment of deviation.
4. Investigation and Root cause analysis
- Review the history of similar type of deviation
- Review of impacted product, material, equipment and process.
- Review of pre and post batches if required.
- Review data related to deviation like BMR, stability sample and qualification and validation documents.
- Review APQR
- Investigate and find out most probable and definitive root cause using risk management tools such as;
5. Identify and implement CAPA
6. CAPA compliance and training
7. Final impact analysis
- Severity Evaluation
- Detection Evaluation
- Occurrence Evaluation
- Criticality Level
- Criticality Grid