Analytical Method Validation- A Comprehensive Guide
This article contains about Analytical method validation process, parameters, Advantages and prerequisites.
Analytical Method Validation- A Comprehensive Guide
What is mean by Analytical Method Validation?
Analytical method validation is a type of validation which certify that method is capable of providing consistently precise ,Valid and Replicable results that can be used to make the further major decisions about the quality of drug product or drug substances.
It involves a series of tests and experiments to evaluate the performance of the method under various conditions. This is an important step in the development and regulatory approval of pharmaceuticals industries that require quantitative measurements of Sample analysis.
The Validation process for any Introduction of new product includes the following steps:
- Method Development: The first step is to develop the analytical method and optimize it for the specific product and sample type.
- Method Qualification: This step involves evaluating the performance of the method in terms of accuracy, precision, repeatability specificity, linearity, range, limit of detection (LOD), limit of quantification (LOQ), and robustness.
- System Suitability Testing: This is a set of tests to ensure that the analytical system is working properly, and that the results obtained are within the expected and targeted range.
- Method Validation: This step involves performing a series of tests to demonstrate that the method is capable of producing accurate and reliable results over time and under various conditions.
- Method Transfer: This is the process of transferring the validated method from one laboratory to another, or from one instrument to another, to ensure that the results obtained are consistent across different locations.
- Method Verification: This step involves performing periodic checks to ensure that the method continues to produce accurate and reliable results over time.
What are the Advantages of Method Validation ?
It ensures that the analytical method is accurate, reliable, and consistent for its intended use, which increases confidence in the method and improves the quality of the data obtained from it. Enlisted some of the advantages as Below :
- Ensures Accuracy and Reliability of Results: Method validation ensures that the analytical method is accurate, reliable, and consistent for its intended use. in short the results obtained from the method are trustworthy and can be used to make critical decisions about the quality and safety of a product.
- Reduces Errors and Variability: Method validation helps to identify and eliminate sources of errors and variability in the analytical method, which can lead to inconsistent or incorrect results. This improves the quality of the data and may reduces the need for repeat testing.
- Increases confidence in the Method: Method validation provides a comprehensive assessment of the analytical method and increases confidence in the method and ensures that it is fit for purpose.
- Ensures compliance with Regulatory Requirements: Method validation is a regulatory requirement for the approval of pharmaceutical products which are supplied to the regulated markets which require quantitative measurements of drug substances or drug products. By conducting method validation, Pharmaceutical industries can ensure that they are in compliance with regulatory requirements and avoid potential regulatory issues.
- Improves Efficiency and Productivity: By optimizing and validating the analytical methods, pharma industries can reduce the time and resources required for testing, and increase the efficiency and productivity of their operations.
Prerequisites for the Analytical Method Validations.
- Method validation should done in line with approved validation protocol and a results of validation study is to be summarized in validation report.
- Well characterized reference materials with documented purity should be used for Method validation and verification.
What are the required parameters for Analytical Method validation procedure ?
Below are the required parameters for Analytical Method validation procedure to take in to consideration but not limited to..
- Specificity
- Precision,
- Accuracy
- Limit of Detection
- Limit of Quantification
- Linearity
- Robustness
- Range
- Solution Stability
Below are the parameters should be validated for analytical procedures.
Assay : Specificity, Linearity, Precision, Accuracy, Range, Robustness, Solution stability,
Dissolution : Specificity, Linearity, Precision, Accuracy, Range ,Robustness , Solution stability
Related Substances : Specificity, Linearity, Precision, Accuracy, LOD (Limit Of Detection), LOQ (Limit of Quantification), Range, Robustness, Solution Stability.
