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.

 REFERENCE:

• Chapter 1 – Pharmaceutical Quality System: 1.8 (xii), 1.10 (iii)
• Chapter 8 – Complaints and Product Recall: 8.12–8.16
• ICH Q9 & Q10: Risk management and continual improvement framework.

RECORDS:

 REVISION HISTORY.