SOP for Analyst Validation | Procedure for the Validation of an Analyst

This document details the procedure for the validation of an analyst. It is the policy of Pharmaceuticals/Chemicals that a written procedure shall be followed and its use monitored to ensure that analysts working in Analytical Division/ Quality Control undergo validation exercise in order to ensure that testing results provided by him/her are trustworthy.

This procedure is to be applied at the time of joining of new analyst and periodical validation exercise.  

RESPONSIBILITY

Persons along with their responsibilities are given below:

S. No	Designation	Responsibility
01	Executive – Corporate Quality Assurance	Preparation of SOP for analyst validation.
02	Manager – Quality Assurance	Implementation of the SOP and interpret the performance of the analyst.
03	Manager  -    Quality Control	To ensure implementation of SOP.
04	Manager  – Corporate Quality assurance	To ensure implementation of SOP.

Analyst Validation Procedure

Selection of testing materials

For the first time of validation of analyst, the material with supplier’s test report (traceable to authentic testing agency) shall be taken as the testing material.

Materials already approved by Analytical Division, Quality Control, or supplier test report (traceable to authentic testing agency) shall be taken as testing material for routine validation exercise.

Procedure for validation and Pharmaceutical validation Analyst job Description

For routine analysis, all analysts shall undergo a validation exercise.

Materials Under test with quality monograph (Standard Test Procedure) shall be provided to each analyst.

Only quantitative tests (Assay and other if any) shall be considered for evaluation exercise but the entire test of STP shall be conducted by each analyst.

Manager Technical / Quality control Manager will give his recommendation to QA Manager.

The analyst shall provide test results to the Technical / Quality Assurance Manager within the due time of the test period. In case of availability of only one instrument in the Analytical Division / Quality Control time for analysis shall be set accordingly.

Repetition of the test(s) shall not be allowed to the analyst.

After completion of the test, the Technical Manager / Quality Control Manager shall check the test result and fill the record on CQA/SOP-004/FR-01 Analyst Validation Report (Appendix I).

Technical Manager / Quality Control Manager shall give his recommendation to QA Manager.

QA Manager shall review validation report and shall decide the selection of analyst for routine analysis. If an analyst fails to qualify for the test, he/she shall undergo re-training on testing equipment and test procedure.

After training analyst shall undergo a re-validation exercise of analyst validation.

Interpretation

The result provided by the analyst shall be cross-checked with the previous result of the material.

If an approved analyst has not tested the material earlier, the supplier report shall be considered as acceptance criteria for validation exercise.

If the analyst fails to qualify the test, as per the vendor report, another approved analyst confirms the result of the vendor report and shall do a repeat test.

Results must be ±1% for assay and ±0.5% for water/ Loss on Drying.

In case three or more analysts are under evaluation then % Relative Standard Deviation shall be taken for interpretation of the result. The % RSD should not be more than 1% among them.

The result of an analyst should not vary by defined acceptance criteria to the actual result (test report) of the material.

Fill the result in the validation report format on CQA-004/FR-01 Analyst Validation Report (Appendix –I).

Frequency: All existing analysts shall be evaluated once a year and new analysts before starting routine analytical work in the Analytical division.

ABBREVIATIONS

APL:  Arbro Pharmaceuticals Limited

CQA:  Corporate Quality Assurance

SOP:  Standard Operating Procedure

FR:  Format

HOD:  Head of Department

CCR:  Change Control Reference

RSD:  Relative Standard Deviation

QA:  Quality Assurance

QC:  Quality Control

HR:  Human Resources

No.:  Number

NMT:  Not more than

CQA/SOP-004/FR-01

APPENDIX I

Analyst Validation Report

DATE:

Test material :__________________________________________________________________

Test Parameter_________________________________________________________________

Result of test parameter (as per approved test report)___________________________________

Name of Analysts	Result Obtained test parameter		Tolerance
			± 1 % for assay ± 0.5% for water loss on drying
Average
Std Deviation
% RSD
Limits (for RSD)	NMT 1%	NMT 1%

Comments:     __________________________________________________________________

Result checked by: ___________________________                     Date:   ___________________

(QC Manager/ Manager Technical)

Final Recommendation:

Selected for routine testing           Not Selected for routine testing

Comments:     __________________________________________________________________

________________________________________________________________

Sign:

 

Quality Assurance Manager _________      Date : ____________________

Sign. of Analyst:______________________