CAPA is taken to correct or rectify the problem or incident or deviation or event etc.

Corrective Action :

An action taken to eliminate the cause of the existing deviation , incident or problem in order to prevent its reoccurrence (occurring again).

Preventive Action :

An action taken to eliminate the cause of potential deviation, incident or problem in order to prevent its occurrence (an incident or event).

Corrective Action and  Preventive Action can be routed or generated from the following activities (But not Limited To ) :

1. Deviation

2. Customer and Regulatory Audits at the site

3. Critical equipment / instrument breakdown

4. Customer/ Regulatory complaints or Market Complaints

5. Product recalls

6. Repeated failures of the systems

7. Vendor audits

8. Self Inspection at site (whether Internal or Corporate Quality Assurance)

9. Rejections of the material (Raw materials, Packing materials and Finished Product)

10. Management review meetings for the GMP system

11. Annual Product Quality Reviews

12. Out of Specification

13. Out of Trend

14. Incidents

15. Mock exercises e.g. recall, safety mock drill, etc

Procedure :

Based on the investigation report the Head of impacted department or the Investigation team shall identify and propose the CAPA to address the incident occurred and avoid its reoccurrence

The responsible department Head/Designee shall fill the CAPA form and send the CAPA form to QA.

CAPA shall be Approved by Head QA/Designee  & after approval from Head Quality Assurance CAPA number shall be allotted and the same shall be entered in CAPA Logbook.

Monitoring, Completion and verification of CAPA :

Authorized persons from QA shall monitor the CAPA for its completion.

On Completion of required actions the department head shall certify that proposed CAPA is completed and implemented.

QA shall verify the implementation and completion of CAPA by review of supporting documents and certify the same.

Based upon the CAPA the required changes done shall be shared to the user and other impacting department and required training shall be imparted.

CAPA shall be completed and closed within the Target Completion date (TCD) and if not completed within the TCD can be revised with appropriate justification.

Two extensions shall be allowed and if the CAPA is not completed after second extension then Quality Risk Assessment report shall be prepared by the user department.

Effectiveness of CAPA :

CAPA effectiveness shall be done with Trend review of various CAPAs derived from incidents or events.

CAPA effectiveness check include the review of the repetitive CAPAs & the same shall be considered satisfactory if no repetitive CAPA is observed.

CAPA effectiveness check can also be verified from the review system like Annual Product Quality Review and during internal audit.

Spot Check can also performed for CAPA effectiveness check. Example Suppose some procedure was newly implemented in batch record & training was imparted for the same but whether the same is followed or not that has to be checked.

Monitoring is used for real-time observations over a defined period to check CAPA effectiveness.

CAPA should be review Annually which contains number of CAPA initiated throughout the year, Open & closed CAPAs, Department wise, number of CAPA closed within Target completion date (TCD) etc.

CAPA Form is given Below for Reference :

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