Protocol for Setting up and Conducting Analytical Runs in BA/BE Studies

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the setup, execution, and documentation of analytical runs conducted in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the planning, preparation, and execution of analytical runs, including Analytical Chemists, Laboratory Technicians, and Study Coordinators.

Responsibilities

• The Analytical Chemist or designated personnel are responsible for planning and overseeing the setup and conduct of analytical runs, ensuring adherence to protocol requirements and regulatory standards.
• The Laboratory Technician is responsible for performing sample preparation, instrument setup, and data acquisition during analytical runs, following established procedures and safety guidelines.
• The Study Coordinator is responsible for coordinating sample collection, labeling, and tracking, and ensuring timely delivery of samples to the laboratory for analysis.

Procedure

1. Review the study protocol and analytical methods to determine the scope, objectives, and requirements for the analytical run.
2. Prepare the laboratory space and analytical instruments for the planned analytical run, ensuring cleanliness, calibration, and availability of required supplies and reagents.
3. Prepare samples for analysis according to the study protocol, including sample dilution, extraction, derivatization, or any other required pre-treatment steps.
4. Set up the analytical instrument according to the method parameters, including instrument settings, column equilibration, and detector conditions.
5. Perform system suitability tests (SST) or quality control checks to verify the performance of the analytical system before sample analysis.
6. Execute the analytical run by injecting samples into the instrument, acquiring chromatographic data, and monitoring instrument performance throughout the run.
7. Record all relevant run parameters, including injection volumes, retention times, peak areas, and any deviations or instrument malfunctions encountered.
8. Analyze acquired data using appropriate software tools, perform calculations or integrations as needed, and review data for accuracy and completeness.
9. Document all analytical run activities, including sample preparation, instrument setup, data acquisition, and data analysis, in the laboratory notebook or electronic records.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence

Documents

• Analytical Run Logbook
• Sample Preparation Records
• Instrument Calibration Records
• Data Analysis Reports

Reference

International Conference on Harmonisation (ICH) Q2(R1) Validation of Analytical Procedures and relevant regulatory guidance documents for analytical method validation and execution.

SOP Version

Version 1.0