Analytical Instrument Qualification (AIQ) in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting analytical instrument qualification (AIQ) during the analytical method development process, ensuring that analytical instruments meet predefined acceptance criteria.

2) Scope

This SOP applies to all personnel involved in AIQ 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 AIQ.

4) Procedure

1. Selection of Analytical Instrument:
   1. Select appropriate analytical instrument based on method requirements and regulatory guidelines.
   2. Verify instrument suitability for intended use and method parameters.
2. Installation Qualification (IQ):
   1. Verify that the instrument is properly installed according to manufacturer specifications.
   2. Document installation qualification activities and results.
3. Operational Qualification (OQ):
   1. Verify that the instrument operates within defined parameters under normal operating conditions.
   2. Perform tests to demonstrate instrument functionality and accuracy.
4. Performance Qualification (PQ):
   1. Validate the instrument’s performance through testing with standard samples.
   2. Document performance qualification activities and results.
5. Data Analysis and Reporting:
   1. Analyze AIQ testing data to assess instrument compliance with acceptance criteria.
   2. Document AIQ results and conclusions in an AIQ report.
6. Review and Approval:
   1. Review the AIQ report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the AIQ report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• AIQ Report
• Installation Qualification Records
• Operational Qualification Records
• Performance Qualification Records
• Review and Approval Records

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