Limit of Quantification (LOQ) Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting limit of quantification (LOQ) testing during the analytical method development process, determining the lowest concentration of an analyte that can be reliably quantified with acceptable precision and accuracy.

2) Scope

This SOP applies to all personnel involved in LOQ testing for analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in LOQ testing.

4) Procedure

1. Selection of Analytical Method:
   1. Select appropriate analytical method based on method requirements and regulatory guidelines.
   2. Verify method suitability and performance characteristics.
2. Preparation of Sample Series:
   1. Prepare a series of samples with decreasing concentrations of the analyte, covering the expected LOQ range.
   2. Ensure accurate preparation and labeling of sample series.
3. Execution of LOQ Testing:
   1. Analyze each sample in the series using the selected analytical method.
   2. Determine the concentration at which the analyte can be reliably quantified with acceptable precision and accuracy (LOQ).
4. Data Analysis and Reporting:
   1. Analyze LOQ testing data to determine the LOQ value based on statistical methods.
   2. Document LOQ testing results and conclusions in an LOQ testing report.
5. Review and Approval:
   1. Review the LOQ testing report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the LOQ testing report.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to LOQ testing in analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• LOQ Testing Report
• Sample Series Preparation Records
• Data Analysis and Results Documentation
• Review and Approval Records
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• USP General Chapter Validation of Analytical Procedures
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0