The aim of the document is to contribute to the understanding of a quality risk management approach in the handling of deviations from a practical perspective as per WHO expectations on the matter.
The document is in line with documents like ICH Q10 Pharmaceutical Quality System, and ICH Q9 Quality Risk Management like WHO, FDA, and EU requirements.
Procedure:
Deviation:
- Any departure from an approved instruction or established standards [Glossary of ICH Q7 – Good manufacturing guide for active pharmaceutical ingredients]
Event Categorization:
- Identification of an Event- Anything that happens or takes place, especially important for notification.
- The decision tree described in the Flow diagram Diagram is a simplified risk assessment that answers the following questions when an event is encountered:
- Effect on the product attribute
- Effect on manufacturing operational parameter.
- Effect on the Product Quality.
- Contradict or omit specified requirements.
- Effect on the cGMP
- The specified requirements mentioned may be from any of the following:
- Standard Operating procedures that may cover any subject.
- Inspection and testing protocols.
- Customer-specified requirements.
- Regulatory requirement.
- Technical instruction.
- Specified parameters written in forms and formats, log books and registers.
- HACCP plan.
- Drawing
- Specifications
Incidents:
- If the answer is NO for questions 1.2.2.1 and 1.2.2.5 above, the event may be considered an Incident.
- On the contrary, if any of the answer for questions 1.2.2.1 and 1.2.2.5 is YES the event shall follow the path towards a deviation category.
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Deviation:
- A deviation is a situation that has occurred either in a planned or unplanned manner. It may be on a product or a process.
Planned Deviation: Any deviation from a documented procedure or specified requirement adopted deliberately as a temporary measure.
Unplanned Deviation: Any deviation occurred in an unintentional manner due to system failure, equipment breakdown, human error or any unforeseen circumstances.
- Minor Deviation - When the deviation does not affect any quality attributes, operational or manufacturing parameters, or equipment or instrument associated with the process, it is considered as a Minor deviation.
- Major Deviation - When the deviation affects the quality attributes, operational or manufacturing parameters, or a piece of equipment or instrument associated with the process, of which the impact to personnel/environment is unlikely, the deviation is categorized as a Major deviation.
- Critical Deviation - When the deviation affects the quality attributes, operational or manufacturing parameters, or an equipment or instrument associated with the process, of which the impact to personnel/environment is highly probable is categorized as critical deviation
ALSO READ: SOP for Handling of Deviation
Event Handling
- Identification of an Event - Anything that happens or takes place, especially important for notification.
- Whenever such an event comes to notice use the format of deviation. to identify whether it is an incident or Deviation and to classify it as a planned or unplanned deviation.
- If it is an unplanned deviation than use the format unplanned deviation to classify it as minor, major or critical.
- If it is a planned deviation then use format No F03 (Change control format)
- If it is and minor deviation/incident than use the format minor deviation
Steps to handling Minor Deviation/Incident:
- Description of an Event
- Correction
- Efficacy and Conclusion
- Recording
- Monitoring
NOTE:
Minor deviations shall be reviewed by Manager QA, recommended by the department HOD, and approved by Head QA.
Handling major deviations/critical deviations
- Description of an event
- Correction
- Efficacy and Conclusion
- The investigation shall be done by using the 5 why techniques etc.
- An investigation report shall be generated which shall have the below contents but not limited to :
- Reason for investigation (what event or finding prompted investigation, how and when happened)
- Describe what happened (when and where)
- Identify other batches/lots affected
- Identify root cause
Quality Impact
- The Quality impact shall be assessed by Quality Risk Management SOP. If there is a quality impact the product is considered as a non-conforming product.
- Recommendation from the department head, approval from Head QA and authorization by Director TQM.
- Validation impact/supporting document.
- Assessment of validation impact (Shall be done by Departmental Head/Head QA and Director TQM)
- CAPA
- Efficacy of corrective action
- Conclusion
Note: Major/Critical deviation shall be reviewed by Manager QA, recommended by the department HOD and approved by Head QA, and authorized by Director TQM.
Handling of Planned deviation
- Description of an event
- Justification for the requirement of planned deviation
- Quality Impact
- The Quality impact shall be assessed by Quality Risk Management SOP. If there is a quality impact the product is considered as non-confirming product
- Validation impact/supporting document.
- Assessment of validation impact.
- CAPA
- Efficacy of corrective action
- Conclusion
- Recording
- Monitoring
Note: Planned deviation shall be reviewed by Manager QA, recommended by department HOD and approved by Head QA and authorized by Director TQM.
- QA shall retain the records irrespective of the approved/reject status of the deviation report and a photocopy of the same shall be filed with the subjected batch manufacturing/packing record/analytical reports.
- Wherever a deviation could affect multiple batches, e.g. due to equipment or facility failure or material or process deviation report, a photocopy of the same shall be filed with the subjected batch manufacturing/packing record / analytical report.
- If it is found that the deviation occurred on account of a faulty procedure or process, the action shall be taken to amend the concerned document under the company’s document change system for necessary amendments to affected documents.
- QA personnel shall maintain the deviation log, department-wise, and year-wise as per the Deviation Control Log.
- Deviation/INCIDENT control numbering system
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