Topic
Method ValidaationnR n
22
SSubmitted t
MMs.Khujasta Nawaz Kh
Course Code
CHEM-205
1
, Table of Contents
1 Introduction..................................................................................................................................3
1.1 Definition...............................................................................................................................3
1.2 Purpose..................................................................................................................................3
1.3 Importance.............................................................................................................................3
2 Parameters of Method Validation.................................................................................................3
2.1 Selectivity and Specificity...................................................................................................4
2.2 Linearity...............................................................................................................................4
2.3 Range....................................................................................................................................5
2.4 Accuracy...............................................................................................................................5
2.5 Precision...............................................................................................................................5
2.6 Limit of Detection................................................................................................................6
2.7 Limit of Quantitation..........................................................................................................6
2.8 Ruggedness...........................................................................................................................7
2.9 Robustness............................................................................................................................7
3 Role of regulatory guidelines (e.g., ICH, FDA, AOAC) in method validation...........................7
4 Types of Validation......................................................................................................................8
4.1 Process Validation...............................................................................................................8
4.2 Analytical Method Validation............................................................................................8
5 Types of analytical procedures to be validated:...........................................................................9
5.1 Identification tests...............................................................................................................9
5.2 Quantitative tests and Limit tests for impurity control...................................................9
5.3 Quantitative tests of the active moiety in samples of drug substance or drug product 9
6 Steps involved in Method Validation...........................................................................................9
7 Conclusion.................................................................................................................................10
8 References..................................................................................................................................11
2
Method ValidaationnR n
22
SSubmitted t
MMs.Khujasta Nawaz Kh
Course Code
CHEM-205
1
, Table of Contents
1 Introduction..................................................................................................................................3
1.1 Definition...............................................................................................................................3
1.2 Purpose..................................................................................................................................3
1.3 Importance.............................................................................................................................3
2 Parameters of Method Validation.................................................................................................3
2.1 Selectivity and Specificity...................................................................................................4
2.2 Linearity...............................................................................................................................4
2.3 Range....................................................................................................................................5
2.4 Accuracy...............................................................................................................................5
2.5 Precision...............................................................................................................................5
2.6 Limit of Detection................................................................................................................6
2.7 Limit of Quantitation..........................................................................................................6
2.8 Ruggedness...........................................................................................................................7
2.9 Robustness............................................................................................................................7
3 Role of regulatory guidelines (e.g., ICH, FDA, AOAC) in method validation...........................7
4 Types of Validation......................................................................................................................8
4.1 Process Validation...............................................................................................................8
4.2 Analytical Method Validation............................................................................................8
5 Types of analytical procedures to be validated:...........................................................................9
5.1 Identification tests...............................................................................................................9
5.2 Quantitative tests and Limit tests for impurity control...................................................9
5.3 Quantitative tests of the active moiety in samples of drug substance or drug product 9
6 Steps involved in Method Validation...........................................................................................9
7 Conclusion.................................................................................................................................10
8 References..................................................................................................................................11
2
