Correction-corrective action and preventive action in pharma:
Correction-corrective action and preventive action are the 3 key definitions used in the pharmaceutical industry while investigating.
Let’s understand the definitions of all with examples.
Correction:
Action to eliminate the detected nonconformity.
Nonconformity is nothing but the non-fulfillment of a specified requirement.
A correction is when you fix the thing that went wrong ( the non-conformity) or to contain the problem.
For Example, Reworking, repair or replacement are corrections.
Corrective Action:
Action to eliminate the cause of a detected nonconformity.
A corrective action (CA) deals with a nonconformity that has occurred i.e. the corrective action is performed on detected non-conformity.
The objective of CA is to prevent a recurrence.
For Example: Installing the filter after an incidence of filter choking.
Corrective action is a reaction that can be made along with the correction.
Preventive Action:
Action to eliminate a cause of a potential nonconformity.
Preventive action determines and eliminates the cause of potential non-conformities to prevent occurrence.
The objective of PA is to prevent its occurrence.
For Example: Installing an alarm to warn you when your process is drifting out of the acceptance range.
Preventive action is proactive.
Quick Recap & key Insights of CAPA:
| Corrective Action | Preventive Action |
| Deals with a nonconformity that has occurred | Deals with potential nonconformities- no failure has yet occurred. |
| The objective of CA is to prevent a recurrence | The objective of PA is to prevent the occurrence |
| Focuses on past events | Focuses on potential future events |
| Requires root cause analysis | Requires risk/or trend analysis |
| Eg. Installing a backup filter after an incidence of filter choking | Eg. Installing an alarm to warn you when your process is drifting out of acceptable range. |
The ratio of CA/PA provides insights into the maturity of the Quality Management System of any organization.
Also Read:
- CAPA process in Pharmaceutical Management System
- FAQ on FDA’s Data integrity
- Dissolution calibration in pharma
- Computer system validation in pharma
- Definitions of terminologies used in OOS
- Basic Factors of cleaning validation
Refer YT Channel: Pharmabeej
