Auditee: Validating analytical methods used in quality control is crucial to ensure the accuracy, reliability, and consistency of test results. Here’s an explanation of our process for validating analytical methods:
Step 1: Method Selection
- Method Identification: The specific analytical method to be validated is selected based on its relevance to the product, regulatory requirements, and industry standards.
- Method Characteristics: The method’s critical attributes, such as sensitivity, specificity, precision, accuracy, and linearity, are defined and documented.
Step 2: Method Development
- Experimental Design: A robust experimental plan is designed to optimize the method’s parameters, conditions, and variables.
- Parameter Optimization: Variables like reagents, equipment settings, and sample preparation techniques are optimized to achieve the best results.
Step 3: Method Validation
- Accuracy and Precision: Accuracy is evaluated by comparing results to a known standard or reference method. Precision is assessed by repeated testing of the same samples.
- Specificity: The method’s ability to differentiate between analytes of interest and potential interferences is tested.
- Linearity: The method’s linear range and response to different concentrations are determined to ensure accurate quantification.
- Limit of Detection (LOD) and Limit of Quantitation (LOQ): The lowest concentration of analyte detectable and quantifiable by the method is established.
Step 4: Method Transfer
- Inter-laboratory Comparison: If the method will be used in multiple laboratories, a study is conducted to ensure consistent results across different sites.
- Protocol Standardization: Detailed protocols, procedures, and documentation are developed to ensure uniform method execution.
Step 5: Documentation and Reporting
- Validation Protocol: A validation protocol outlines the scope, objectives, testing procedures, acceptance criteria, and roles of individuals involved.
- Validation Report: A comprehensive report summarizes the validation process, results, deviations encountered, and conclusions reached.
Step 6: Ongoing Monitoring and Review
- Periodic Review: Validated methods are subject to periodic reviews and, if necessary, revalidation to ensure their continued fitness for purpose.
- Change Management: Any changes to the method, equipment, or procedures trigger a review to assess the impact on method performance and necessitate revalidation if required.
Through this comprehensive process, we ensure that our analytical methods used in quality control are validated, robust, and capable of providing accurate and reliable results that meet regulatory requirements and uphold product quality and safety.