How can you validate analytical methods for Biotechnology product development?

1 Define the objective

The first step in validating an analytical method is to define the objective of the method, and the performance characteristics that need to be evaluated. The objective should be clear and specific, and should align with the regulatory requirements and the intended use of the method. For example, the objective of a method for quantifying a protein product in a formulation could be to measure the concentration and purity of the protein with a high degree of accuracy and precision. The performance characteristics that need to be evaluated for this method could include accuracy, precision, specificity, linearity, range, and robustness.

2 Design the validation protocol

The second step in validating an analytical method is to design a validation protocol, which is a document that describes the rationale, scope, methodology, acceptance criteria, and data analysis of the validation study. The validation protocol should be based on the objective and the performance characteristics of the method, and should follow the relevant ICH guidelines. For example, the validation protocol for a method for quantifying a protein product in a formulation could follow the ICH Q2(R1) guideline on validation of analytical procedures, and could specify the number and type of samples, the calibration curve, the reference standards, the validation parameters, and the statistical methods to be used.

3 Execute the validation study

The third step in validating an analytical method is to execute the validation study, which is the experimental phase where the method is tested and evaluated according to the validation protocol. The validation study should be performed under controlled and standardized conditions, and should generate sufficient and representative data to demonstrate the performance of the method. The data should be recorded and documented in a clear and traceable manner, and should be checked for any errors or deviations. For example, the validation study for a method for quantifying a protein product in a formulation could involve testing different batches of the product, different concentrations of the product, different instruments and operators, and different environmental factors.

4 Analyze the validation data

The fourth step in validating an analytical method is to analyze the validation data, which is the statistical phase where the data is processed and interpreted to assess the performance of the method. The data analysis should be performed according to the validation protocol, and should use appropriate and validated statistical tools and methods. The data analysis should provide numerical and graphical results for each validation parameter, and should compare them with the acceptance criteria. For example, the data analysis for a method for quantifying a protein product in a formulation could provide results for accuracy, precision, specificity, linearity, range, and robustness, and could use regression analysis, confidence intervals, and hypothesis testing.

5 Report the validation results

The fifth step in validating an analytical method is to report the validation results, which is the documentation phase where the results are summarized and presented in a validation report. The validation report should be concise and comprehensive, and should include the following elements: the objective, the validation protocol, the validation data, the data analysis, the conclusions, and the recommendations. The validation report should also include any deviations, limitations, or assumptions that may affect the validity of the method. For example, the validation report for a method for quantifying a protein product in a formulation could include a summary table of the results for each validation parameter, a graphical representation of the calibration curve, and a discussion of the sources of variability and uncertainty.

6 Review and approve the validation report

The sixth and final step in validating an analytical method is to review and approve the validation report, which is the verification phase where the report is evaluated and authorized by the relevant stakeholders. The review and approval process should ensure that the validation report is complete, accurate, and consistent, and that it meets the regulatory and quality standards. The review and approval process should also involve a feedback and improvement mechanism, where any issues, gaps, or suggestions are identified and addressed. For example, the review and approval process for a method for quantifying a protein product in a formulation could involve a peer review by other analysts, a quality review by the quality assurance department, and a regulatory review by the regulatory affairs department.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?