What should an analyst do during analytical method validation?
The responsibilities of an analyst /chemist during method validation typically include the following:
Designing the Validation Protocol: The analytical chemist is responsible for developing a detailed validation protocol that outlines the objectives, scope, acceptance criteria, and experimental procedures for method validation.
Selecting Representative Samples: They must select appropriate test samples that are representative of the matrix or analyte of interest. These samples should cover the expected range of concentrations and conditions encountered during routine analysis.
Instrumentation and Equipment: Ensure that the analytical instrumentation and equipment used for validation are properly calibrated and maintained. This includes verifying that the equipment is capable of generating accurate and precise results.
Performing Validation Experiments: Conduct a series of experiments as per the validation protocol. This involves analyzing the selected samples using the analytical method under consideration. The experiments should cover key validation parameters, including specificity, accuracy, precision, linearity, range, limit of detection (LOD), limit of quantification (LOQ), and robustness.
Data Analysis: Analyze the experimental data and compare the results against predefined acceptance criteria. This involves statistical analysis to determine if the method meets the required standards for accuracy, precision, and other parameters.
Documentation and Reporting: Keep thorough and organized records of all validation activities, including sample preparation, data collection and analysis. Prepare a comprehensive validation report summarizing the results, conclusions and any deviations.
Validation Review: Collaborate with peers or senior scientists to review and discuss validation results to ensure their accuracy and reliability.
Method Transfer: If the validated method is to be transferred to other laboratories, the analytical chemist may be responsible for providing training and guidance to ensure consistent and accurate implementation.
Continuous Monitoring: After method validation, the analytical chemist should monitor the ongoing performance of the method during routine use, conduct periodic revalidation as necessary and make necessary adjustments or improvements.
Compliance: Ensure that the method validation process complies with relevant regulatory guidelines and industry standards.
Communication: Collaborate with other team members, stakeholders, and regulatory agencies as needed to communicate and address validation-related issues and findings.
Read also:
- Errors or Incidences During Analytical Method validation
- Analytical Method Validation in Pharmaceutical Industry
- Analytical Method Development Process
Resource Person: Jairus Fernandes