Learn about the major and minor deviaitons that occur in pharmaceuticals and an outline on how to treat them
Controlling deviation is an integral part of quality risk management and in turn helps in maintaining quality with continuous improvement. CAPA process helps in detecting the deviation and analyzing from root cause and implementing the corrective action. The process of handling deviations involves the steps like identifying, categorizing and investigating the deviation along with root cause analysis.
Minor deviations are the deviation that doesn’t affect quality attribute or any critical process. Major deviations are the ones which cause deviation in a quality of the product or process or in equipment.
Process:
When an event arises that causes a significant impact on various parameters of manufacturing process or deviating from SOPs or GMPs then its impact is evaluated.
Basing on impact caused by the event it is determined as minor or major deviation
Steps for treating minor deviations:
1. Description: The minor deviation is documented in a clear and concise manner about time, location and person who found deviation.
2. Correction: Minor deviations are addressed as corrections which includes problem description and immediate action. They should be approved by QA before implementing. Most of the deviations require a change control rather than root cause analysis.
3. Efficacy and Conclusion: Document is done providing a conclusion along with the outcome of the action.
4. Database record: The information should be documented in log books or batch records and stored so that it can be used in future for investigation or quality reviews.
Steps for treating major deviations:
1. Description: Major deviations are documented by a thorough and enhanced research with a specific objective.
2. Correction: After the deviations are addressed as corrections and approved by QA department then analysis is done.
3. Efficacy of correction: Sometimes minor deviations that occur repeatedly tend to turn into major deviations. Corrective actions should be taken to segregate minor and major deviations without failure.
4. Root cause Investigation: As discussed under CAPA, basing on Fault tree analysis, 5 whys and Fishbone diagrams root causes in various departments are analyzed.
5. CAPA: Corrective and preventive actions are taken basing on the corrections. These actions should be approved by QA.
6. Efficacy of corrective action: The CAPA system should be evaluated for its efficacy and the outcomes of implemented actions.
7. Conclusion: The course of action should be concluded on its approach and outcome.
8. Database record: The information generated due to the major deviation should be documented in log books or batch records for quality reviews or investigation in future.
Major deviation, minor deviation, capa
