SOP for Analyst Validation

OBJECTIVE

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

SCOPE

This SOP is applicable to establish the capability of analysts to perform analysis accurately.

RESPONSIBILITY

Officer -Quality Control

ACCOUNTABILITY

Manager - Quality Control

PROCEDURE

• Samples of known analytical values shall be identified by the Quality Control Manager.
• The analytical value(s) of a sample(s) along with acceptable limit(s), AR No., and Code No. shall be recorded by the Quality Control Manager in a register maintained for this purpose.
• All the coded samples shall be kept in sealed vials at 2-8°C or as per sample requirement.
• The coded samples along with the necessary information required for analysis shall be disclosed to the analyst.
• Materials already approved by the QC laboratory or supplier test report (traceable to an authentic testing agency) will be taken as testing material for routine validation exercises. 
• The analyst shall be validated for either one or more of the following areas of analysis.

1. Assay
2. Moisture content
3. Melting point
4. Identification by IR Spectrophotometer

• 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

• The analyst's results shall be checked for cGLP compliance and compared with expected values.
• Materials Under test with quality monograph (Standard Test Procedure) will provided to each analyst.
• No repeat of the test will be allowed to the analyst.
• The capability to perform tests by the Analyst shall be considered satisfactory if the results reported by the analyst are within the acceptable limits.
• The analyst shall be revalidated after a period of two years.
• The details like calculations, chromatograms, and strip charts along with comments of the Manager -Quality Control shall be filed in the training file of analysts.
• The new analysts shall be validated within one year of joining.
• After completion of the test, the QC Manager will check the test result and fill the record.
• The QC Manager will give his recommendation to the QA Manager.
• The QA Manager will review the validation report and decide on an analyst's selection for routine analysis. If the analyst fails to qualify the test analyst will undergo training in testing equipment and test procedures.
• The results are provided by the analyst will be crosschecked with the previous result of the material and check the similarity of the results.
• If material is not previously tested in the company by an approved analyst the supplier report will be considered acceptance criteria for validation exercise. If an analyst fails to qualify the test, as per the vendor report, another approved analyst to confirm the result of the vendor report will do a repeat test.
• In case of three or more analysts are under evaluation then % Relative Standard Deviation will be taken for interpretation of the result. The % RSD should not be more than 1%.
• The result of the analyst should not vary by defined acceptance criteria to the actual result (test report) of the material.
• Fill in the result in the analyst validation report (Annexure-1).

ANNEXURE

Annexure-1: Analyst Validation Report

ABBREVIATIONS

SOP: Standard Operating Procedure 

QC: Quality Control

GLP: Good Laboratory Practice

REVISION HISTORY

Nil

ALSO READ: SOP for Out of Calibration of Laboratory Instruments