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:
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.