Pharmaceutical Bioequivalence Study Audit Checklist

Bioequivalence study audits should be conducted at key stages: before study initiation (protocol review), during the study conduct (in-process audit), and after study completion (final audit). Additionally, specific audits may be performed for analytical method validation and pharmacokinetic analysis.

This checklist covers study protocol compliance, subject selection and informed consent processes, dosing and sample collection procedures, bioanalytical method validation, pharmacokinetic data analysis, statistical analysis, data integrity, and regulatory documentation requirements.

These audits are typically conducted by clinical research auditors, quality assurance specialists, or bioequivalence study experts with in-depth knowledge of regulatory requirements and Good Clinical Practice (GCP) guidelines.

The checklist ensures that all aspects of the bioequivalence study meet regulatory standards, including FDA, EMA, and WHO guidelines for bioequivalence studies, which are crucial for the approval of generic drugs and biosimilars.

If significant deviations are identified, actions should include immediate assessment of the impact on study validity, investigation of root causes, implementation of corrective measures, potential amendment of study protocols or analytical methods, and in severe cases, consideration of study repetition. All actions must be thoroughly documented and reported to sponsors and relevant regulatory authorities if required.