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.
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.
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.
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.
- 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