Standard Operating Procedure for CAPA (Corrective and Preventive Actions)

1) Purpose

This SOP outlines the procedures for initiating, investigating, implementing, and verifying corrective and preventive actions (CAPA) to address non-conformances, deviations, and potential issues in order to prevent their recurrence.

2) Scope

This SOP applies to all departments involved in the manufacturing, testing, and quality assurance of pharmaceutical products within the company.

3) Responsibilities

The Quality Assurance (QA) department is responsible for overseeing the CAPA process. All personnel are responsible for identifying potential CAPAs, documenting them, and supporting investigations and implementation.

4) Procedure

4.1 CAPA Initiation

1. Identify and document potential CAPAs through various sources, such as deviations, complaints, audits, and quality control data.
2. Record the CAPA details in the CAPA Initiation Form, including the description of the issue, its impact, and initial risk assessment.
3. Assign a CAPA number and designate a CAPA owner responsible for leading the investigation and implementation.

4.2 Investigation

1. Conduct a thorough investigation of the issue or non-conformance identified, using appropriate root cause analysis tools and techniques.
2. Collect and analyze relevant data, documents, and evidence to determine the root cause(s) of the issue.
3. Document the investigation findings in the CAPA Investigation Report Form, including the identified root cause(s) and supporting evidence.

4.3 CAPA Plan Development

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Based on the investigation findings, develop a comprehensive CAPA plan that addresses the root cause(s) identified.

Define clear and achievable corrective actions to address the immediate issue and preventive actions to prevent recurrence.

Include specific action items, responsible parties, timelines, and success criteria for each CAPA.

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4.4 CAPA Implementation

1. Implement the CAPA plan as defined, ensuring all corrective and preventive actions are carried out within the specified timelines.
2. Verify that the implemented actions effectively address the root cause(s) and mitigate the identified risks.
3. Document the implementation details and any changes made during the process.

4.5 CAPA Effectiveness Verification

1. Verify the effectiveness of implemented CAPAs through follow-up activities, such as monitoring, testing, or additional audits.
2. Evaluate whether the CAPAs have achieved their intended objectives and prevented recurrence of the issue.
3. Document the results of the effectiveness verification in the CAPA Effectiveness Verification Report Form.

4.6 Closure and Review

1. Review all documentation related to the CAPA process, including investigation reports, CAPA plans, implementation records, and effectiveness verification reports.
2. Close the CAPA once all actions have been successfully completed and verified.
3. Conduct a final review to ensure all documentation is complete, accurate, and compliant with regulatory requirements.

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4.7 Documentation and Records

1. Maintain complete and accurate records of all CAPA activities, including CAPA Initiation Forms, Investigation Reports, CAPA Plans, Implementation Records, and Effectiveness Verification Reports.
2. Ensure that all documentation is readily accessible for audits and regulatory inspections.

5) Abbreviations, if any

QA: Quality Assurance
SOP: Standard Operating Procedure
CAPA: Corrective and Preventive Actions

6) Documents, if any

CAPA Initiation Form, Investigation Report Form, CAPA Plan, Implementation Records, Effectiveness Verification Report Form

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)

8) SOP Version

Version 1.0