STANDARD OPERATING PROCEDURE ANALYTICAL METHOD VALIDATION

STANDARD OPERATING PROCEDURE

SUBJECT :                     ANALYTICAL METHOD VALIDATION

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

           

To provide guidelines for analytical method validation.

2.0       POLICY:       

To lay down a procedure for analytical method validation.

3.0       PROCEDURE:

                       

3.1       Whenever a new product is manufactured analytical method is to be validated.

3.2       In case of loan license products validated method will be furnished by the party.

3.3       The ruggedness of the method is checked. In case the method is to be validated then the performance characteristics of the method should meet the requirements for the intended analytical application. Performance characteristics are expressed in terms of analytical parameters.

Typical analytical parameters used in Assay validation are

3.3.1    Accuracy                                

3.3.2    Precision

3.3.3    Specificity                              

3.3.4    Limit of detection

3.3.5    Limit of quantitation   

3.3.6    Linearity

3.4       In case of validated method verification of analytical method is done and the RSD of results obtained should be less than 2%.

4.0       FREQUENCY: As and when New Product is manufactured.

5.0       RESPONSIBILITY: General Manager QA

6.0       REVIEW GUIDE: Validation record.

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x