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