Standard Operating Procedure for Corrective and Preventive Actions (CAPA) in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to establish a standardized procedure for identifying, implementing, and documenting corrective and preventive actions (CAPA) to address quality issues, deviations, and non-conformances in the production of transdermal patches, ensuring continuous improvement and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in the production, quality control, and quality assurance of transdermal patches, as well as any other departments that may contribute to or be affected by CAPA activities.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for overseeing the CAPA process. All personnel are responsible for identifying potential quality issues and participating in the implementation and documentation of CAPA measures.

4) Procedure

4.1 Identification of Issues

• 4.1.1 Identify quality issues, deviations, non-conformances, or any other events that require corrective or preventive actions through routine inspections, audits, testing, or reports from personnel.
• 4.1.2 Report identified issues to the supervisor and the QA Department using the CAPA Request Form.
• 4.1.3 Document the details of the issue, including date, time, description, and any immediate actions taken, in the CAPA Request Form.

4.2 CAPA Assessment and Planning

• 4.2.1 The QA Department conducts an initial assessment of the reported issue to determine its potential impact on product quality, safety, and regulatory compliance.
• 4.2.2 Categorize the issue based on its severity (e.g., minor, major, critical) and prioritize CAPA activities accordingly.
• 4.2.3 Develop a CAPA Plan outlining the steps to be taken to investigate the issue, identify root causes, and implement corrective and preventive actions.
• 4.2.4 Assign responsibilities for each step of the CAPA Plan to appropriate personnel or departments.

4.3 Investigation and Root Cause Analysis

• 4.3.1 Conduct a thorough investigation to identify the root cause(s) of the issue using appropriate tools and techniques, such as the 5 Whys, Fishbone Diagram (Ishikawa), or Failure Mode and Effects Analysis (FMEA).
• 4.3.2 Review relevant process steps, equipment, materials, and personnel involved in the issue.
• 4.3.3 Collect and analyze data, including batch records, equipment logs, and test results, to identify potential contributing factors.
• 4.3.4 Document the investigation findings, including identified root cause(s) and contributing factors, in the CAPA Report.

4.4 Implementation of Corrective Actions

• 4.4.1 Develop and implement corrective actions to address the immediate cause(s) of the issue and prevent recurrence.
• 4.4.2 Ensure that corrective actions are practical, effective, and sustainable.
• 4.4.3 Document all corrective action activities, including action plans, responsible personnel, and completion dates, in the CAPA Report.

4.5 Implementation of Preventive Actions

• 4.5.1 Identify and implement preventive actions to eliminate the root cause(s) and prevent similar issues from occurring in the future.
• 4.5.2 Ensure that preventive actions are practical, effective, and sustainable.
• 4.5.3 Document all preventive action activities, including action plans, responsible personnel, and completion dates, in the CAPA Report.

4.6 Review and Approval

• 4.6.1 The QA Department reviews the completed CAPA Report, including corrective and preventive action activities, to ensure adequacy and completeness.
• 4.6.2 Obtain final approval from the QA Manager or designee before closing the CAPA report and implementing any long-term process changes.

4.7 Documentation and Trending

• 4.7.1 Maintain all CAPA reports and related documentation in a centralized CAPA Log.
• 4.7.2 Conduct periodic reviews and trend analysis of CAPA findings to identify patterns or areas for process improvement.
• 4.7.3 Implement process improvements based on trending analysis to enhance product quality and compliance.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
FMEA: Failure Mode and Effects Analysis

6) Documents, if any

CAPA Request Form
CAPA Report
CAPA Log
Batch Records
Investigation Documentation

7) Reference, if any

ICH Q10: Pharmaceutical Quality System
21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0