SOP for Analyst Validation

Standard operating procedure to Validate the analyst for analysis. 

1.0 OBJECTIVE
To lay down a procedure to establish capability of analyst to perform analysis accurately.

2.0 SCOPE
This SOP is applicable to establish capability of analyst to perform analysis accurately.

3.0 RESPONSIBILITY
Officer -Quality Control 

4.0 ACCOUNTABILITY
Manager - Quality Control 

5.0 PROCEDURE
5.1 Samples of known analytical values shall be identified by the Quality Control
Manager. 
5.2 The analytical value(s) of sample(s) along with acceptable limit(s), AR No., and Code
No. shall be recorded by Quality Control Manager in a register maintained for this
purpose. 
5.3 All the coded samples shall be kept in sealed vials at 2-8° C or as per sample
requirement. 
5.4 The coded samples along with necessary information required for analysis shall be
disclosed to the analyst. 
5.5 Materials already approved by QC laboratory or supplier test report (traceable to
authentic testing agency) will be taken as testing material for routine validation exercise. 
5.6 The analyst shall be validated for either one or more of following areas of analysis. 
1. Assay 
2. Moisture content 
3. Melting point 
4. Identification by IR Spectrophotometer 
5.7 The validation shall include one or more of the following methods of analysis: 
1. HPLC
2. UV Spectrophotometer 
3. Titrimetry 
4. KF analysis 
5. Melting point analysis 
6. IR Spectrophotometer
5.8 The results of analyst shall be checked for cGLP compliance and compared with
expected values.
5.9 Materials Under test with quality monograph (Standard Test Procedure) will provided
to each analyst.
5.10 No repeat of test will be allowed to the analyst.
5.11 The capability to perform tests by Analyst shall be considered satisfactory if the
results reported by the analyst are within the acceptable limits.
5.12 The analyst shall be revalidated after a period of two years.
5.13 The details like calculations, chromatograms, and strip charts along with comments
of Manager -Quality Control shall be filed in training file of analysts.
5.14 New analyst shall be validated within one year of joining.
5.15 After completion of test the QC Manager will check the test result and fill the
record.
5.16 QC Manager will give his recommendation to QA Manager.
5.17 QA Manager will review validation report and will decide for the selection of analyst
for routine analysis. If analyst is failed to qualify the test analyst will undergo training to
testing equipment and test procedure.
5.18 The result are provided by analyst will be crosscheck to the previous result of the
material and check the similarity of the result.
5.19 If material is not previously tested in the company by approved analyst the supplier
report will be considered acceptance criteria for validation exercise. If analyst is failing to
qualify the test, as per vendor report, another approved analyst to confirm the result of
the vendor report will do a repeat test.
5.20 In case of three or more analyst are under evaluation then % Relative Standard
Deviation will be taken for interpretation of the result. The % RSD should not be more
than 1%.
5.21 The result of analyst should not vary by defined acceptance criteria to actual result
(test report) of the material.
5.22 Fill the result in analyst validation report.

6.0 ABBREVIATIONS
6.1 SOP - Standard Operating Procedure
6.2 QC – Quality Control
6.3 GLP – Good Laboratory Practice
 Analyst Validation Report

Name of
analyst:_______________________________________________________________________
___________________________
Test
Parameter:____________________________________________________________________
_______________________________
Sample:_______________________________________________________________________
_________________________________

Sample Description Results Tolerance %

Limit Variation
Code No AR No./ B.No Test parameter Initial Validation
Results Results

Comments:____________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
__________________________________________

Result checked By:___________________________     Date _____________________________

Final Recommendation:

Selected for routine testing                                                    Not Selected for routine testing   

            
Comments:_________________________________________________________________________________
______________________________________________________________________________________________
______________________________________________________________________________________________
___________________________________________________________________________

Q C Manager :

Date :