CAPA is a fundamental quality management tool for pharmaceutical industry. Implementing an effective corrective or preventive action capable of satisfying regulatory authorities also.
Corrective Action
The action was taken to rectify, fix or correct a specific deviation, defect or undesirable situation.
Preventive Action
The action was taken to eliminate the cause of deviation, defect, or other undesirable situation in order to prevent the future occurrence of such or similar an event.
CAPA Process Steps
- Initiate CAPA request and submit for review
- Accept or reject the CAPA request
- The request is formally initiated as a CAPA
- Determine a CAPA
- Involve cross-functional team
- Identify any immediate actions or corrections required
- Investigate and capture findings
- Determine a root cause
- Develop an action plan
- Complete the action plan
- Review CAPA for completeness
In summary it is accomplished in seven basic steps:
- Identification
- Evaluation
- Investigation
- Analysis
- Action Plan
- Implementation
- Follow Up
CAPA Closure and Verification
- On completion of actions, the department head shall certify that the proposed CAPA is completed and implemented along with associated actions.
- QA shall verify the implementation and completion of CAPA with the review of supporting documents and certify the same.
- Any change proposed as a result of CAPA shall be through the SOP on Change Control Reference of the same shall be mentioned in the CAPA format.
- All Change Controls, Deviations, Incident Reports giving rise to CAPA shall be addressed through CAPA form.
- Information and documents related to CAPA drawn from internal audits, external/ Customer audits and regulatory inspections are considered confidential and can only be available to regulatory review.
Source documents of CAPA are identified as:
- GMP Investigations
- Deviations
- Change control
- (OOS) Investigations
- Internal Audit Reports
- External / Customer Audits
- Annual Product Reviews
- Regulatory Inspection Reports
- Management Action Plans
- Changes in regulatory
- Product Failures
- Complaints
- Product recall
- Returned Goods
- Incidence Reports
Examples of CAPA in Pharma Industry
Incident/Reason: “Checked by” option is missing after calculation of average tablets/capsule weight in mg.
Root Cause: Typographical Error
CAPA: Batch manufacturing record should be updated including “Checked by” option after calculation of overall Average tablets/capsule weight in mg.
Incident/Reason: IPC specification of BMR and protocol of tablets are found mismatch.
Root Cause: Typographical Error
CAPA: IPC specification to be synchronized between the BMR and protocol of tablets.
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Resource Persons: Hassan Hussein
Please share few CAPA example in pharmaceutical manufacturing.