Standard Operating Procedure for Analytical Method Validation
1) Purpose
The purpose of this SOP is to establish procedures for the validation of analytical methods used in the testing of dental dosage forms, ensuring accuracy, reliability, and compliance with regulatory requirements.
2) Scope
This SOP applies to the analytical method validation activities conducted for testing dental pastes, gels, and mouthwashes within the pharmaceutical industry.
3) Responsibilities
The Quality Control (QC) Department is responsible for executing analytical method validation activities. The Quality Assurance (QA) Department is responsible for reviewing and approving validation protocols and reports.
4) Procedure
4.1 Method Validation Protocol Development
4.1.1 Develop a method validation protocol outlining validation objectives, acceptance criteria, and testing methods specific to analytical techniques.
4.1.2 Identify critical method parameters (CMPs) and performance characteristics to be validated.
4.2 Method Suitability Testing
4.2.1 Perform method suitability tests to demonstrate that the analytical method is suitable for its intended purpose.
4.2.2 Evaluate method specificity, accuracy, precision, linearity, and robustness as applicable.
4.3 Method Validation
4.3.1 Execute method validation experiments using appropriate samples and conditions.
4.3.2 Validate the method performance by analyzing validation samples and comparing results against predefined acceptance criteria.
4.4 System Suitability Testing
4.4.1 Conduct system suitability tests to ensure the analytical system is capable of producing valid results consistently.
4.4.2 Monitor system suitability parameters and document results as per protocol requirements.
4.5 Validation Report
4.5.1 Compile all method validation data and results into a comprehensive validation report.
4.5.2 Document conclusions, deviations, and corrective actions taken during the method validation process.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QC – Quality Control
QA – Quality Assurance
6) Documents, if any
Method Validation Protocol
Method Validation Reports
Validation Summary Report
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
ICH guidelines for analytical method validation
8) SOP Version
Version 1.0
