Protocol for Ensuring Quality in BA/BE Study Execution

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures and responsibilities for ensuring the quality of Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the planning, execution, and oversight of BA/BE studies, including Study Coordinators, Clinical Research Associates (CRAs), Principal Investigators, and Quality Assurance personnel.

Responsibilities

• The Study Coordinator is responsible for coordinating study activities, ensuring compliance with study protocols, and facilitating communication between study personnel.
• The Clinical Research Associate (CRA) is responsible for monitoring study conduct, verifying data integrity, and ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
• The Principal Investigator is responsible for overall study oversight, participant safety, and data integrity, and ensuring that study procedures are conducted according to protocol and regulatory standards.
• The Quality Assurance (QA) personnel are responsible for conducting quality audits, reviewing study documentation, and providing recommendations for improvement to ensure study quality and compliance.

Procedure

1. Establish a Quality Assurance Plan outlining the procedures, responsibilities, and frequency of quality audits, reviews, and inspections throughout the study conduct.
2. Conduct regular audits of study documentation, including informed consent forms, study protocols, case report forms (CRFs), and data management procedures, to ensure compliance with regulatory requirements and GCP guidelines.
3. Review study conduct procedures, including participant recruitment, screening, enrollment, and follow-up, to ensure adherence to protocol requirements and participant safety.
4. Assess data integrity and accuracy by comparing source documents with study records, verifying data entry and transcription accuracy, and identifying and addressing discrepancies or inconsistencies.
5. Monitor investigational product handling, storage, administration, and accountability procedures to ensure compliance with protocol requirements and Good Manufacturing Practice (GMP) guidelines.
6. Provide feedback and recommendations for improvement to study personnel based on audit findings, ensuring that corrective and preventive actions are implemented in a timely manner.
7. Maintain records of quality assurance activities, including audit reports, findings, corrective actions, and follow-up activities, in accordance with regulatory requirements and study procedures.
8. Report serious breaches of protocol, regulatory non-compliance, or significant quality issues to the appropriate authorities, including sponsors, institutional review boards (IRBs), and regulatory agencies, as required.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• CRA – Clinical Research Associate
• GCP – Good Clinical Practice
• QA – Quality Assurance
• GMP – Good Manufacturing Practice
• IRB – Institutional Review Board

Documents

• Quality Assurance Plan
• Quality Audit Reports
• Corrective and Preventive Action (CAPA) Plans
• Communication Log

Reference

International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory requirements for quality assurance in clinical research.

SOP Version

Version 1.0