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 comprehensive validation reports summarizing method performance and validation outcomes.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
HPLC: High-Performance Liquid Chromatography
GC: Gas Chromatography
6) Documents, if any
– Analytical Method Development Protocols
– Method Validation Reports
– Feasibility and Optimization Studies
7) Reference, if any
– ICH Q2(R1): Validation of Analytical Procedures
– USP General Chapter <1225> Validation of Compendial Procedures
– Company-specific analytical method development guidelines and procedures
8) SOP Version
Version 1.0