How do you plant the Analytical method validation Activity?
Let me take you through the process in a nut-shell -
Define the Purpose
State the purpose and objective of the method validation. Determine whether it's for regulatory compliance, new method, change in analytical method etc.
Regulatory Requirements
Review the relevant regulations and guidelines (e.g., FDA, ICH, USP) to ensure you meet their requirements.
Pre-Validation Study
Before the formal validation, perform preliminary experiments to optimize the method conditions and assess its suitability. This includes selecting suitable instrumentation, conditions, short study on validation parameters etc.
Validation Protocol
- Develop detailed validation protocols that outline the validation procedures, acceptance criteria and all necessary steps.
- Determine which analytical parameters you need to validate. Common parameters include accuracy, precision, specificity, linearity, range, robustness, and stability.
Select Validation Samples
Decide on the types of samples to use for validation. These samples should represent the matrix or matrices that the method will encounter in routine use.
Materials and Instruments Requirement
- Ensure readiness of Instruments and equipment which should be qualified and calibrated.
- Use characterized working standards along with COAs etc.
Analysis
Execute the validation experiments according to the defined protocol. This includes collecting data for each parameter of interest and analyzing the results.
Documentation
- Maintain detailed records of all validation activities, including protocols, raw data-chromatograms, spectra, calculation sheets, and results.
- Proper documentation is critical for regulatory compliance and transparency.
Evaluate and Interpret Results
Assess the validation results critically. Determine whether any adjustments or improvements to the method are necessary based on the data and findings which includes precautions, notes to be added to the method.
Validation Report
Compile all the validation data, results, and interpretations into a comprehensive validation report. This report should provide evidence of the method's accuracy and suitability for its intended purpose.
Routine Use
Once the method is validated and approved, it can be implemented for routine use. Ensure that all personnel are trained in the validated method's procedures.
Continuous Monitoring
Regularly monitor the performance of the validated method through ongoing quality control checks and instrument calibration. Implement a system for handling deviations and changes.
Read also:
- Validation of Compendial Methods
- Analytical Procedure Lifecycle
- Guidance for Analytical Method Transfer
Resource Person: Jairus Fernandes
