Protocol for Validation of Bioanalytical Methods in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the validation of bioanalytical methods used for the quantitative analysis of drug compounds and metabolites in biological samples collected from study participants in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the development, validation, and implementation of bioanalytical methods, including Analytical Chemists, Laboratory Managers, and Quality Assurance personnel.

Responsibilities

• The Analytical Chemist or designated personnel are responsible for developing and validating bioanalytical methods according to established guidelines and regulatory requirements.
• The Laboratory Manager is responsible for overseeing method validation activities, ensuring compliance with SOPs and regulatory standards.
• The Quality Assurance (QA) personnel are responsible for reviewing and approving method validation protocols, reports, and documentation to ensure data integrity and regulatory compliance.

Procedure

1. Plan and design the validation study based on regulatory guidelines, study objectives, and method development results.
2. Conduct pre-validation experiments to optimize method parameters, such as selectivity, specificity, sensitivity, accuracy, precision, and linearity.
3. Prepare a validation protocol outlining the study objectives, experimental design, acceptance criteria, and analytical procedures to be validated.
4. Perform the validation experiments according to the protocol, including sample preparation, analytical measurement, and data analysis.
5. Evaluate the validation results against predefined acceptance criteria and assess the method’s performance characteristics.
6. Prepare a validation report summarizing the study design, experimental results, and conclusions, including any deviations or challenges encountered during the validation process.
7. Review the validation report with the Quality Assurance (QA) team for approval and ensure that all required documentation is completed and filed appropriately.
8. Implement the validated method for routine sample analysis in BA/BE studies, ensuring ongoing compliance with method validation requirements and quality standards.

Abbreviations

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

Documents

• Validation Protocol
• Validation Report
• Pre-validation Experiment Records
• QA Approval Documentation

Reference

International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines and relevant regulatory guidance documents for bioanalytical method validation.

SOP Version

Version 1.0