Method Validation: Understanding the Process
Analytical Method validation allows to quality control department to check the authenticity of analysis results obtained by a particular method of analysis applied to the product. AMV has four major goals ACCURACY, SPECIFICITY, LINEARITY & ROBUSTNESS. Every AMV should achieve these four goals to be successful. Therefore, a periodical Analytical Method validation plan should be practiced in the Quality Control Department. Quality Control (QC) in the Pharmaceutical Industry implements Analytical Method validation with the following steps:-
Method validation is required for any new or amended method to ensure that it is capable of giving reproducible and reliable results.
What is method validation?
Validation of an analytical method is the process by which it is established by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical application.
The requirement of method validation or revalidation
Procedure
If the method is official in Pharmacopoeia, then partial validation is required and if it is in house method then all these points shall be performed.
Precision: The precision of an analytical method is the degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of a homogeneous sample under normal operating circumstances. Precision may be considered at three levels: repeatability, intermediate precision, and reproducibility.
Repeatability: Repeatability expresses the precision under the same operating conditions over a short interval of time.
Intermediate Precision: Intermediate Precision expresses within laboratories variations: different days, different analysts, different types of equipment, etc.
Reproducibility: Reproducibility expresses the precision between laboratories (collaborative studies, usually applied to the standardization of methodology)
ACCURACY: Accuracy is a measure of the test results obtained by a method to the true value, which is a measure of the exactness of the analytical method.
SPECIFICITY: Specificity for any assay ensures that the single measure comes from the substances of interest and there is no interference from recipients.
LINEARITY: Linearity is a measure of the method’s ability to obtain results that are either directly or after mathematical transformation proportional to the concentration of the analyte with a given range.
ROBUSTNESS: Robustness of an analytical method parameters and provides an indication of its reliability during normal usage.
References:
- ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology [European Medicines Agency-June 1995 CPMP/ICH/381/95Â ]Â Â
