departments of the API manufacturing facility. It covers both product-specific and system-related issues.

3. Responsibilities

• Initiator: Responsible for raising the CAPA based on identified non-conformance.
• CAPA Coordinator (QA): Responsible for coordinating investigations, reviews, and closure activities.
• Department Head: Assists in identifying root cause and implementation of assigned actions.
• QA Head: Final approver of all CAPAs, ensuring effectiveness and closure.

4. Accountability

The Quality Assurance Department is accountable for overall CAPA system implementation, timely execution, and continuous monitoring to prevent recurrence of quality failures.

5. Procedure

5.1 Sources for CAPA Initiation

CAPAs can be initiated from the following sources:

• Deviations
• Internal/External Audit Observations
• Product Complaints
• Out of Specification (OOS) / Out of Trend (OOT) Results
• Change Controls
• Regulatory Inspections

5.2 CAPA Initiation

1. The concerned department shall raise a CAPA Request using the CAPA Initiation Form (Annexure-1).
2. The form shall include:
   • Reference source (Deviation No., Audit Observation No., etc.)
   • Brief description of issue
   • Immediate correction (if any)
3. Submit the form to QA for review and entry into the CAPA Register (Annexure-2).

5.3 Investigation and Root Cause Analysis

1. The QA representative shall coordinate with relevant department to initiate a detailed investigation.
2. Investigation techniques may include:
   • 5 Whys Analysis
   • Ishikawa/Fishbone Diagram
   • Brainstorming
3. Document findings in the CAPA Investigation Report (Annexure-3).

5.4 Corrective and Preventive Action Planning

1. Based on investigation, define:
   • Corrective Actions: Actions taken to rectify existing non-conformities.
   • Preventive Actions: Actions taken to eliminate potential causes and prevent recurrence.
2. Assign responsible persons and timelines for each action.
3. Record actions and due dates in the CAPA Tracker (Annexure-4).

5.5 Implementation and Effectiveness Check

1. All actions must be implemented as per assigned deadlines.
2. QA shall perform a follow-up to verify the completion and effectiveness of CAPA.
3. Effectiveness check includes:
   • Audit of revised process or document
   • Training verification
   • Monitoring of post-implementation results

5.6 CAPA Closure

1. QA shall close the CAPA only after:
   • Completion of all corrective and preventive actions
   • Successful verification of effectiveness
   • Approval by QA Head
2. Mark the CAPA as ‘Closed’ in the CAPA Register with closure date and remarks.

5.7 Delayed CAPAs

1. If CAPA is not completed by the due date:
   • Extension may be requested with justification
   • Revised timelines shall be approved by QA Head
2. Delayed CAPAs shall be highlighted in monthly quality review meetings.

5.8 Trending and Metrics

1. QA shall analyze CAPA trends monthly for:
   • Frequent issues from the same source
   • Recurrence of similar issues
   • CAPA turnaround time (TAT)
2. CAPA metrics shall be presented during Management Review Meetings.

6. Abbreviations

• CAPA: Corrective and Preventive Action
• QA: Quality Assurance
• QC: Quality Control
• OOS: Out of Specification
• OOT: Out of Trend

7. Documents

1. CAPA Initiation Form (Annexure-1)
2. CAPA Register (Annexure-2)
3. CAPA Investigation Report (Annexure-3)
4. CAPA Tracker (Annexure-4)
5. Effectiveness Check Template

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – Subpart J: Records and Reports
• WHO TRS No. 981 – Annex 2

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: CAPA Initiation Form

CAPA ID	Reference	Description	Raised By	Date
CAPA/2025/014	DEV/2025/032	Repeat deviation during granulation	Rajesh Kumar	12/04/2025

Annexure-2: CAPA Register

CAPA ID	Date	Source	Status	Closed On
CAPA/2025/014	12/04/2025	Deviation	Open	—

Annexure-3: CAPA Investigation Report

CAPA ID	Root Cause	Method Used	Investigated By
CAPA/2025/014	Improper setup of granulator	5 Whys	Sunita Reddy

Annexure-4: CAPA Tracker

Action	Type	Responsible	Due Date	Status
Train operators	Preventive	QA	20/04/2025	Ongoing

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Version	Implementation	QA Head
14/04/2025	2.0	Integrated tracker and effectiveness template	Improvement	QA Head