We hope an analyst can be benefitted from below 38 tips on HPLC method validation from ISO 17025, ICH and USP.
1. Define the purpose and scope of the method validation .
2. Identify the critical parameters of the method.
3. Establish acceptance criteria for each parameter.
4. Select appropriate reference standards and materials.
5. Verify the accuracy and precision of the equipment used.
6. Validate the suitability of the chromatographic system.
7. Evaluate the selectivity and specificity of the method.
8. Determine linearity, range, and limit of detection/quantification (LOD/LOQ).
9. Verify robustness by testing variations in parameters such as pH, temperature, flow rate, etc.
10. Validate sample preparation procedures.
11. Evaluate stability of samples during storage and analysis.
12. Verify repeatability by analyzing multiple samples under identical conditions.
13. Validate intermediate precision by analyzing samples on different days or by different analysts.
14. Determine accuracy by comparing results to a known reference standard or method.
15. Evaluate precision by calculating relative standard deviation (RSD) or coefficient of variation (CV).
16. Verify recovery by spiking known amounts of analyte into a sample matrix and comparing to expected values.
17. Validate system suitability tests (SSTs) for each run to ensure consistent performance over time.
18. Establish documentation requirements for all validation activities performed.
19. Ensure that all validation activities are performed in accordance with ISO 17025, ICH, and USP guidelines and regulations.
20. Use appropriate statistical methods to analyze data obtained during validation studies.
21. Document any deviations from established protocols or procedures during validation studies and their impact on results obtained.
22. Ensure that all personnel involved in validation studies are properly trained on relevant procedures and protocols before beginning work on them.
23. Maintain accurate records of all validation activities performed, including raw data, calculations, and conclusions drawn from them.
24. Ensure that all equipment used in validation studies is properly calibrated before use.
25. Ensure that all reagents and materials used in validation studies are of appropriate quality and purity.
26. Verify that all calculations performed during validation studies are accurate and consistent with established protocols.
27. Ensure that all data generated during validation studies is properly stored, backed up, and secured against loss or corruption.
28. Establish procedures for handling out-of-specification results obtained during validation studies.
29. Ensure that all personnel involved in validation studies are aware of the importance of maintaining confidentiality and security of data generated during these activities.
30. Establish procedures for reviewing and approving validation reports before they are released to stakeholders or regulatory agencies.
31. Ensure that all validation activities are performed in accordance with established timelines and deadlines.
32. Establish procedures for communicating results of validation studies to stakeholders or regulatory agencies.
33. Ensure that all documentation related to validation activities is properly archived and retained for future reference.
34. Verify that all equipment used in validation studies is properly maintained and serviced on a regular basis.
35. Ensure that all personnel involved in validation studies are aware of the importance of adhering to established safety protocols when working with hazardous materials or equipment.
36. Establish procedures for conducting risk assessments prior to beginning work on any new method or procedure.
37. Ensure that all personnel involved in validation studies are properly trained on relevant safety protocols before beginning work on them.
38. Establish procedures for conducting internal audits of the laboratory's quality management system to ensure ongoing compliance with ISO 17025, ICH, and USP guidelines and regulations.
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