Protocol for Addressing Audit Observations in BA/BE Study Facilities

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for responding to audit findings and implementing corrective actions to address deficiencies identified during audits of Bioavailability (BA) and Bioequivalence (BE) study facilities in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the audit response process, including Study Coordinators, Quality Assurance (QA) Officers, Laboratory Managers, and Regulatory Affairs Specialists.

Responsibilities

• The Study Coordinator is responsible for coordinating the response to audit findings, ensuring that corrective actions are implemented in a timely manner.
• The Quality Assurance (QA) Officer is responsible for reviewing audit findings, identifying root causes of deficiencies, and overseeing the corrective action process.
• The Laboratory Manager is responsible for addressing audit findings related to laboratory operations, implementing corrective actions, and ensuring compliance with quality standards.
• The Regulatory Affairs Specialist is responsible for communicating audit findings and corrective actions to regulatory authorities, as required.

Procedure

1. Review audit findings and observations to identify deficiencies and areas requiring corrective action.
2. Assign responsibility for implementing corrective actions to relevant personnel and establish timelines for completion.
3. Investigate root causes of deficiencies to determine underlying issues contributing to the audit findings.
4. Develop and implement corrective action plans to address identified deficiencies, including process improvements, training, and procedural changes.
5. Document all corrective actions taken, including the rationale for the actions, responsible personnel, and completion dates.
6. Monitor the implementation of corrective actions to ensure that they are effective in addressing audit findings and preventing recurrence of deficiencies.
7. Verify the effectiveness of corrective actions through follow-up audits or inspections to confirm that deficiencies have been resolved.
8. Communicate the status of corrective actions to relevant stakeholders, including auditors, sponsors, and regulatory authorities.
9. Update relevant documentation, including standard operating procedures (SOPs), policies, and training materials, to reflect changes resulting from audit findings and corrective actions.
10. Archive audit response records, including corrective action plans, implementation records, and follow-up reports, in accordance with regulatory requirements and company procedures.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• QA – Quality Assurance

Documents

• Audit Findings Report
• Corrective Action Plan
• Implementation Records
• Follow-Up Audit Reports

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for responding to audit findings in clinical research.

SOP Version

Version 1.0