GMP: ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology (CPMP/ICH/381/95)Objective of validation of an analytical procedure is to demonstrate that it is suitable for the intended purpose. Types of analytical procedures to be validated are:- Identification tests.
- Quantitative tests for impurities‘ content.
- Limit tests for control of impurities
- Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in drug product.
Type of analytical procedure
characteristics | IDENTIFICATION | TESTING FOR IMPURITIES | ASSAY - dissolution (measurement only) - content/potency |
| Qualitat. | Limit | | Accuracy |
- | + | - | + | Precision Repeatability Interm. Precision |
- - | + + | - - |
+ + | Specificity | + | + | + |
+ | Detection Limit | - | - | + |
- | Quantification Limit | - | + |
- | - | Linearity | - | + |
- | + | Range | - | + |
- | + |
|
