Validation, often referred to as method validation, is a crucial process in the laboratory when introducing a new machine, technology, or analytical technique. It involves a series of systematic steps and assessments to ensure that the new method is reliable, accurate, and consistent in generating valid results. Here are key points about validation and method validation:
- Introduction of New Methods: Validation is typically required when a laboratory introduces a new analytical method, instrument, or technology for testing, measurement, or analysis. This can include techniques like chromatography, spectrophotometry, or molecular assays.
- Verification of Performance: The primary goal of validation is to verify that the new method or technology performs as expected and consistently provides accurate and reliable results.
- Validation Procedure: The specific validation process can vary depending on the nature of the method or technology being validated. However, it typically involves a series of well-defined steps and criteria.
- Known Samples: One common validation aspect is running known samples, often called validation or control samples. These samples are carefully selected, prepared, and analyzed using the new method.
- Portfolio of Results: The results obtained from analyzing known samples are compiled into a portfolio or dataset. This dataset is examined and subjected to various statistical and analytical assessments.
- Performance Evaluation: During the validation process, the method’s performance is evaluated based on criteria such as accuracy, precision, specificity, sensitivity, linearity, and robustness. These criteria may vary depending on the type of analysis being conducted.
- Acceptance Criteria: Acceptance criteria are established before validation begins. These criteria define the minimum acceptable performance levels the new method must meet for validity.
- Documentation and Reporting: Rigorous documentation is a key aspect of validation. All aspects of the validation process, including procedures, results, and any deviations from acceptance criteria, are thoroughly documented and reported.
- Time-Consuming Process: Method validation can be time-consuming, especially when working with large numbers of known samples. The process may involve the analysis of tens or even hundreds of samples.
- Regulatory Requirements: In regulated industries such as pharmaceuticals, food safety, and clinical diagnostics, validation is often a mandatory requirement to ensure compliance with regulatory standards and guidelines.
- Implementation: Once a new method successfully passes validation and meets the defined acceptance criteria, it can be implemented into the laboratory’s routine procedures for analysis.
- Continuous Monitoring: After implementation, ongoing monitoring and quality control measures are essential to ensure that the method continues to perform reliably over time.
In summary, method validation is a rigorous and systematic process used to assess the performance and reliability of a new analytical method, instrument, or technology in the laboratory. It involves the analysis of known samples, documentation of results, and adherence to acceptance criteria to ensure that the method is fit for its intended purpose and consistently produces valid data.
