Protocol for Conducting Audits in BA/BE Study Facilities

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting audits of clinical and bioanalytical facilities involved in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in auditing activities, including Auditors, Quality Assurance (QA) Officers, Study Coordinators, and Laboratory Managers.

Responsibilities

• The Auditor is responsible for planning, conducting, and reporting audit findings for clinical and bioanalytical facilities.
• The Quality Assurance (QA) Officer is responsible for overseeing the audit process, ensuring compliance with audit procedures, and reviewing audit reports.
• The Study Coordinator is responsible for facilitating access to study documentation and facilities during the audit process.
• The Laboratory Manager is responsible for coordinating audit activities related to bioanalytical facilities and addressing any findings related to laboratory operations.

Procedure

1. Plan the audit by defining the scope, objectives, and criteria for auditing clinical and bioanalytical facilities.
2. Notify the facility being audited in advance and schedule the audit at a mutually agreed-upon time.
3. Conduct the audit according to the predefined audit plan, including document review, facility inspection, and interviews with key personnel.
4. Use standardized audit checklists and assessment tools to evaluate compliance with regulatory requirements, study protocols, and standard operating procedures (SOPs).
5. Document audit findings, observations, and non-conformities identified during the audit process.
6. Communicate audit findings to facility management and study personnel during an exit meeting at the conclusion of the audit.
7. Prepare an audit report summarizing audit findings, observations, and recommendations for corrective actions.
8. Review the audit report with facility management and study personnel to ensure accuracy and completeness of the report.
9. Follow up on corrective actions taken by the facility to address audit findings and verify the effectiveness of corrective actions through follow-up audits or inspections.
10. Archive audit records, including audit plans, checklists, reports, and correspondence, in accordance with regulatory requirements and company procedures.

Abbreviations

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

Documents

• Audit Plan
• Audit Checklist
• Audit Report
• Corrective Action Plan

Reference

International Council for Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidelines for conducting audits in clinical research.

SOP Version

Version 1.0