Standard Operating Procedure for Stability Study Analytical Method Validation

Purpose

The purpose of this SOP is to establish procedures for the validation of analytical methods used in stability studies for pharmaceutical products.

Scope

This SOP applies to all personnel involved in the development and execution of stability study analytical methods.

Responsibilities

• Quality Assurance: Responsible for overall oversight and approval of the analytical method validation process.
• Analytical Laboratory: Responsible for conducting method validation experiments and ensuring compliance with established procedures.
• Regulatory Affairs: Responsible for providing regulatory guidance on method validation requirements.

Procedure

1. Define the scope and objectives of the analytical method validation in accordance with regulatory requirements and study protocols.
2. Conduct a risk assessment to identify critical method parameters and potential sources of variability.
3. Develop a validation protocol outlining the experimental design, acceptance criteria, and validation schedule.
4. Perform precision, accuracy, linearity, specificity, and robustness studies as applicable to the specific analytical method.
5. Document all validation experiments, including raw data, calculations, and any deviations from the protocol.
6. Evaluate the results of the validation experiments against pre-established acceptance criteria.
7. Prepare a validation report summarizing the results, conclusions, and any recommendations for method improvements.
8. Obtain approval from the Quality Assurance department before implementing the validated analytical method in stability studies.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Analytical Method Validation Protocol
• Validation Report
• Method Validation Log

Reference

ICH Q2 (R1) – Validation of Analytical Procedures

SOP Version

Version 1.0