Protocol for Ensuring Quality in Bioanalytical Testing

Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for maintaining quality control in bioanalytical laboratories conducting analysis for Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in bioanalytical testing, including Laboratory Analysts, Quality Control Officers, Study Coordinators, and Laboratory Managers.

Responsibilities

• The Laboratory Analyst is responsible for performing bioanalytical tests accurately and in compliance with established procedures and quality standards.
• The Quality Control Officer is responsible for implementing quality control measures, monitoring assay performance, and ensuring compliance with regulatory requirements.
• The Study Coordinator is responsible for coordinating sample collection, labeling, and tracking, and ensuring timely delivery of samples to the laboratory for analysis.
• The Laboratory Manager is responsible for overseeing laboratory operations, implementing quality management systems, and ensuring staff training and competency.

Procedure

1. Establish and maintain a Quality Control Plan outlining the procedures, responsibilities, and frequency of quality control activities in the bioanalytical laboratory.
2. Perform routine calibration and maintenance of analytical instruments according to manufacturer specifications and standard operating procedures.
3. Prepare and analyze quality control samples, including calibration standards, quality control samples, and system suitability samples, to ensure assay accuracy, precision, and reliability.
4. Monitor assay performance by analyzing control charts, trend analysis, and statistical process control methods, and take corrective actions as necessary to address deviations or out-of-specification results.
5. Document all quality control activities, including instrument maintenance, sample analysis, and quality control data, in laboratory notebooks or electronic records, following established documentation procedures.
6. Review and verify analytical data for accuracy, completeness, and compliance with regulatory requirements and study protocols, and ensure that data are reported in a timely and accurate manner.
7. Participate in proficiency testing programs and external quality assessments to evaluate laboratory performance and identify areas for improvement.
8. Implement corrective and preventive actions to address deficiencies identified during internal or external audits, and ensure that corrective actions are effective in preventing recurrence of quality issues.

Abbreviations

• SOP – Standard Operating Procedure
• BA – Bioavailability
• BE – Bioequivalence
• QC – Quality Control

Documents

• Quality Control Plan
• Instrument Calibration Records
• Quality Control Sample Analysis Records
• Corrective and Preventive Action (CAPA) Reports

Reference

International Council for Harmonisation (ICH) Q2(R1) Validation of Analytical Procedures and relevant regulatory guidelines for bioanalytical method validation and quality control in bioanalysis.

SOP Version

Version 1.0