1) SOP for CAPA (Corrective and Preventive Actions)

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for identifying, documenting, and implementing corrective and preventive actions (CAPA) in response to quality issues, non-compliances, and potential risks, to ensure continuous improvement and regulatory compliance.

3) Scope

This SOP applies to all quality-related issues and non-compliances identified within the pharmaceutical manufacturing facility, including deviations, customer complaints, audit findings, and internal assessments.

4) Responsibilities

• Quality Assurance (QA) Department: Responsible for overseeing the CAPA process, including investigation, documentation, and implementation of corrective and preventive actions.
• Department Heads: Responsible for initiating CAPA within their respective departments and ensuring timely implementation of corrective and preventive actions.
• All Employees: Responsible for reporting quality issues and participating in the CAPA process as required.

5) Procedure

1. Identification of Quality Issues
   1. Identify quality issues through various sources such as deviations, audit findings, customer complaints, or internal assessments.
   2. Document the issue in a CAPA report, providing a detailed description of the problem and its impact on product quality and compliance.
2. Initiation of CAPA
   1. Assign a unique CAPA number to each identified issue for tracking purposes.
   2. Assign responsibility for the CAPA to the relevant department or individual.
   3. Establish a timeline for the investigation and resolution of the issue.
3. Investigation and Root Cause Analysis
   1. Conduct a thorough investigation to determine the root cause of the quality issue.
   2. Use appropriate root cause analysis tools, such as the Fishbone Diagram, 5 Whys, or Failure Mode and Effects Analysis (FMEA).
   3. Document the findings of the investigation, including the identified root cause(s).
4. Development of Corrective and Preventive Actions
   1. Develop corrective actions to address the root cause and immediate effects of the quality issue.
   2. Develop preventive actions to prevent recurrence of the issue in the future.
   3. Ensure that actions are specific, measurable, achievable, relevant, and time-bound (SMART).
   4. Document the corrective and preventive actions in the CAPA report.
5. Implementation of Actions
   1. Implement the corrective and preventive actions as per the established timeline.
   2. Ensure that all involved employees are informed and trained on the new procedures or changes.
   3. Monitor the implementation process and document any challenges or deviations.
6. Verification of Effectiveness
   1. Conduct a follow-up review to verify the effectiveness of the implemented actions.
   2. Ensure that the quality issue has been resolved and does not recur.
   3. Document the verification process and findings in the CAPA report.
7. Documentation and Record Keeping
   1. Maintain comprehensive records of all CAPA activities, including investigations, actions, and verification results.
   2. Ensure that CAPA records are readily accessible for audits and inspections.
   3. Retain CAPA records for the required period as per regulatory and company policies.
8. Continuous Improvement
   1. Regularly review CAPA data to identify trends and areas for improvement.
   2. Incorporate lessons learned from CAPA activities into the quality management system.
   3. Encourage a culture of continuous improvement and proactive problem-solving among employees.

6) Abbreviations, if any

• CAPA: Corrective and Preventive Actions
• QA: Quality Assurance
• FMEA: Failure Mode and Effects Analysis

7) Documents, if any

• CAPA Reports
• Root Cause Analysis Tools and Reports
• Training Records

8) Reference, if any

• International Conference on Harmonisation (ICH) Q10: Pharmaceutical Quality System
• FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
• Company-specific CAPA procedures and policies

9) SOP Version

Version 1.0