Standard Operating Procedure for Analytical Method Development for Gels

1) Purpose

The purpose of this SOP is to outline procedures for the development and validation of analytical methods used for testing gels to ensure accurate and reliable analytical results.

2) Scope

This SOP applies to all personnel involved in analytical method development for gels within the pharmaceutical manufacturing facility.

3) Responsibilities

Analytical Chemist: Lead analytical method development and validation activities.
Quality Assurance (QA) Team: Review and approve analytical method validation protocols and reports.
Formulation Scientists: Provide input on method requirements based on formulation characteristics.

4) Procedure

4.1 Method Development
4.1.1 Define analytical requirements based on product specifications and regulatory guidelines.
4.1.2 Evaluate and select appropriate analytical techniques (e.g., HPLC, GC, spectroscopy).

4.2 Method Optimization
4.2.1 Optimize analytical parameters such as mobile phase composition, wavelength, and column temperature.
4.2.2 Conduct feasibility studies to ensure methods are suitable for routine analysis.

4.3 Method Validation
4.3.1 Validate analytical methods according to ICH guidelines or relevant compendia.
4.3.2 Perform validation parameters including specificity, linearity, accuracy, precision, and robustness.

4.4 Documentation and Reporting
4.4.1 Document method development and validation activities in detail.
4.4.2 Prepare