SOP for Analyst Validation/ Qualification in Quality Control

1.0 OBJECTIVE

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

2.0 SCOPE

This SOP is applicable to establish the capability of the 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 the 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 the 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 provide to each analyst.
5.10 No repeat of the 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 the 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 the 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 the material is not previously tested in the company by approved analyst the supplier report will be considered acceptance criteria for validation exercise. If the 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 Results	Validation Results

Comments:___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Result checked By:___________________________     Date _____________________________

Final Recommendation:

Selected for routine testing                                                    Not Selected for routine testing   

          

Comments:_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Q C Manager :

Date :

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