QA010: SOP FOR CAPA

OBJECTIVE:

This document outlines the procedure for administering corrective and preventive actions (CAPA), including tracking and reporting their status.

SCOPE:

This SOP is relevant for procedures for tracking, following up on, and verifying the completion and effectiveness of corrective and preventive actions (CAPA).

RESPONSIBILITIES:

Production Department:

- - Identify and report any deviation, non-conformity, or trend observed during manufacturing, packaging, or in-process checks.
  - Ensure immediate containment actions are taken to prevent recurrence or mix-ups.
  - Support root cause investigation through process and batch record review.
  - Implement approved corrective and preventive actions (e.g., retraining, equipment adjustment, procedure revision).

Quality Assurance (QA):

- Receive and log CAPA requests and assign CAPA numbers.
- Evaluate the impact of the deviation/non-conformance on product quality and patient safety.
- Lead the root cause analysis using structured tools (5 Whys, Fishbone, Pareto).
- Approve CAPA plan, verify implementation, and assess effectiveness through follow-up checks or audits.

Quality Control (QC):

- Report out-of-specification (OOS), out-of-trend (OOT), or analytical deviations through the CAPA system.
- Participate in investigation to establish analytical or material-related causes.
- Verify any corrective actions related to instruments, methods, or analyst practices.

Engineering & Maintenance:

- Provide technical input during investigations involving equipment, utilities, or calibration failures.
- Ensure corrective actions (repairs, re-calibration, PM schedule review) are completed and documented.
- Support preventive actions by recommending design or system improvements.

Warehouse / Stores:

- Report any material handling or storage deviations that may impact quality.
- Support CAPA through traceability of batches and material status verification.

Department Heads:

- Review and approve investigation and CAPA proposals from respective departments.
- Ensure timely implementation and closure of CAPA within defined timelines.

Head – Quality Assurance:

- Review and approve final CAPA reports for adequacy and compliance.

Senior Management:

- Ensure CAPA system effectiveness through resource allocation, management review, and continuous improvement initiatives.

DEFINATIONS:

CAPA (Corrective and Preventive Action): A systematic approach that includes actions taken to eliminate the causes of existing (Corrective) and potential (Preventive) non-conformities to prevent their recurrence or occurrence.
Corrective Action: Action taken to eliminate the root cause of a detected non-conformity or other undesirable situation to prevent its recurrence.
Preventive Action: Action taken to eliminate the cause of a potential non-conformity or undesirable situation to prevent its occurrence.
Deviation / non-conformity: An unplanned departure from an approved instruction, standard, or expected result related to materials, equipment, processes, or systems which may directly or indirectly affect product quality.
Root Cause Analysis (RCA): A structured investigation technique used to determine the underlying reason for a problem or deviation using methods such as 5 Whys, Fishbone Diagram, or Pareto Analysis.
Effectiveness Check: The process of verifying that the implemented corrective or preventive action has successfully removed or controlled the root cause and prevented recurrence.
CAPA Log / Register: A controlled record used by QA to document, monitor, and trend the status of all CAPAs including initiation date, responsible person, target date, and closure date.
Risk Assessment: A systematic process of evaluating potential risks to quality, considering their severity, likelihood, and detectability.

PROCEDURE:

Identification of Non-Conformity / Deviation:

Any deviation, non-conformity, or undesirable trend observed in manufacturing, testing, storage, or distribution must be immediately documented in the Deviation / Incident Log.
The observation shall include details such as date, batch number, location, description, and reporter’s name.
The QA Department shall evaluate if the event requires CAPA initiation based on risk and recurrence potential.

CAPA Initiation:

QA raises a CAPA Request Form (F/QA010/001 – 00) and assigns a unique CAPA number.
CAPA shall be linked with the originating record (Deviation, OOS, Complaint, Audit Observation, etc.).
The CAPA type shall be classified as:
- Critical: Potential impact on patient safety, product quality, or GMP compliance.
- Major: May affect batch consistency or regulatory compliance.
- Minor: No direct impact but requires improvement or monitoring.

Root Cause Investigation:

A cross-functional CAPA Investigation Team (QA, Production, QC, Engineering, and other relevant functions) shall be constituted.
Root cause analysis shall be used to identify the underlying cause(s). tools such as:
- 5 Why Analysis
- Fishbone Diagram (Ishikawa)
- Pareto Chart
- Process Flow Mapping
- Check Sheet: To capture and compile information.
Diagram of Control In order to assess the procedure and verify its stability. All supporting data (batch records, analytical data, maintenance logs, training records, etc.) shall be reviewed.

Impact Assessment:

The team shall assess whether the identified issue has impacted any other batches, processes, or equipment.

Risk assessment shall follow ICH Q9 principles (Severity × Likelihood × Detectability).
If critical impact is suspected, QA shall evaluate batch disposition and regulatory notification requirements.

Development of Corrective and Preventive Actions:

Corrective Actions (CA): Actions taken to eliminate the cause of an identified non-conformity. Examples: procedure revision, retraining, equipment calibration, or process parameter adjustment.
Preventive Actions (PA): Actions to eliminate the potential cause of future occurrences. Examples: system improvement, preventive maintenance change, or process redesign.
Each action shall have a defined responsible person, target completion date, and verification method.

Review and Approval:

QA shall review proposed actions for adequacy, feasibility, and GMP compliance.
The Department Head and QA Head shall approve the CAPA plan prior to implementation.
For critical CAPAs, approval of Quality Head is mandatory.

Implementation and Monitoring:

The responsible department shall implement approved actions within the specified timelines.
QA shall periodically follow up and record the status (Open / In Progress / Completed / Closed).
Any delay must be justified and documented with revised timelines.

Verification of Effectiveness:

QA shall evaluate whether the implemented CAPA effectively eliminated the root cause.

Verification may include:
- Review of subsequent batches or analytical data.
- Internal audit verification.
- Trending of deviations post-implementation.
- If ineffective, the CAPA shall be reopened and re-investigated.

Documentation and Record Retention:

All CAPA records shall be maintained electronically or in hardcopy under document control.
Records include: CAPA form, investigation summary, root cause analysis, approval sheet, and verification report.
Retention period: Minimum 5 years from closure or one year after product expiry, whichever is longer.

Trending and Management Review:

QA shall perform quarterly CAPA trend analysis to identify recurring issues and systemic weaknesses.
If needed, CAPA metrics (e.g., number opened, overdue, by department, by root cause category) shall be presented in Management Review Meetings.
Management shall evaluate resource needs or procedural changes based on CAPA trends.

Closure:

A CAPA shall be closed only when:
- - All corrective and preventive actions are completed.
  - Verification confirms effectiveness.
  - QA Head signs off closure.
  - Closure date shall be documented, and the CAPA status updated in the CAPA Register.

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