Analytical Method Validation is a process which is checked by regulatory bodies to assure whether the new instrument or equipment meets SOP (Guidelines). It is the process of collecting documented evidence whether it performs according to the intended purpose or not. Validation is a basic requirement to ensure quality and reliability of the results for all analytical applications. This type of procedures are often in-house developments and applications. The degree of knowledge and expertise is initially much larger compared with standards and hence it can be defined as:
"Validation is one kind of process by which it is established, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended application".
It should be used for the analysis of drug substance and drug product. For a smooth performance, it is important that the the process documents all the details of performing the analysis. This process should describe in detail the steps necessary to perform the analytical test. This may include but it is not limited to, the principle of the test method, the preparation of samples, reference standards, and any reagents or solutions, the use and required functional specifications of the apparatus, the generation of the calibration curve, system suitability tests (SSTs), and the use of the formulae for the calculations.
It is required when:
- A new method is being developed
- Revision of established method.
- Also required when established methods are used in different laboratories and different analysts.
- Comparison of methods.
- It is also performed when quality control indicates method changes.
- To trust the method
- Regulatory requirement
According to the ICH, the following types of tests may be considered:
- Identification tests: Intended to ensure the identity of an analyte in a sample.
- Quantitative tests for impurities content: Intended to accurately and quantitatively reflect the purity of a sample.
- Limit tests for the control of impurities: Intended to accurately reflect the purity characteristics of a sample as a limit test.
Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product: Intended to accurately and quantitatively measure the analyte present in a sample.