Protocol for Implementing CAPA in BA/BE Study Facilities
Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for identifying, implementing, and verifying corrective and preventative actions (CAPA) to address non-conformities, deficiencies, and potential risks identified during Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.
Scope
This SOP applies to all personnel involved in the CAPA process, including Study Coordinators, Quality Assurance (QA) Officers, Laboratory Managers, and Regulatory Affairs Specialists.
Responsibilities
- The Study Coordinator is responsible for initiating CAPA requests, coordinating CAPA activities, and ensuring timely implementation of CAPA plans.
- The Quality Assurance (QA) Officer is responsible for overseeing the CAPA process, reviewing CAPA requests, and verifying the effectiveness of CAPA actions.
- The Laboratory Manager is responsible for identifying non-conformities and potential risks in laboratory operations, recommending CAPA actions, and monitoring their implementation.
- The Regulatory Affairs Specialist is responsible for ensuring that CAPA activities comply with regulatory requirements and communicating CAPA outcomes to regulatory authorities, as necessary.
Procedure
- Identify non-conformities, deficiencies, deviations, and potential risks through internal audits, inspections, monitoring activities, or incident investigations.
- Document non-conformities and their impact on study conduct, data integrity, participant safety, or regulatory compliance.
- Evaluate the root causes of non-conformities to determine underlying issues contributing to the identified problems.
- Develop CAPA plans to
address identified non-conformities and prevent recurrence of similar issues in the future.
Assign responsibility for implementing CAPA actions to relevant personnel and establish timelines for completion.
Implement CAPA actions according to the defined plan, ensuring that they are effective in addressing root causes and preventing recurrence of non-conformities.
Monitor the implementation of CAPA actions and verify their effectiveness through follow-up activities, such as re-audits, inspections, or performance evaluations.
Document all CAPA activities, including the rationale for CAPA actions, responsible personnel, completion dates, and verification outcomes.
Review and evaluate the effectiveness of CAPA actions periodically to identify any new non-conformities or opportunities for improvement.
Communicate CAPA outcomes and lessons learned to relevant stakeholders, including study personnel, management, sponsors, and regulatory authorities.
Abbreviations
- SOP – Standard Operating Procedure
- BA – Bioavailability
- BE – Bioequivalence
- QA – Quality Assurance
- CAPA – Corrective and Preventative Actions
Documents
- CAPA Request Form
- CAPA Plan
- CAPA Implementation Records
- CAPA Verification Reports
Reference
International Council for Harmonisation (ICH) Q9 Quality Risk Management guidelines and relevant regulatory guidelines for implementing CAPA in the pharmaceutical industry.
SOP Version
Version 1.0
