sop for performance qualification for analyst

Table of Contents

1.0 PROTOCOL APPROVAL
2.0 OBJECTIVE
3.0 RESPONSIBILITY
4.0 ACCOUNTABILITY
5.0 METHOD
6.0 ABBREVIATIONS
7.0 ANNEXURES

1.0 PROTOCOL APPROVAL

Designation
Signature
Date
Prepared By

(Sr. Executive QA)
Checked By

(Manager. Quality Control )
Approved By

(Manager Quality Assurance)

2.0 OBJECTIVE
2.1 To evaluate the Knowledge, Skill, Experience of the Analyst.

3.0 RESPONSIBILITY
3.1 Head – Quality Control.
4.0 ACCOUNTABILITY
4.0 Head – Quality Assurance.
5.0 METHOD
5.1 Samples of known analytical values shall be identified by

the Quality Control Manager.
5.2 The analytical value of sample along with acceptable

limit. A.R. 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 2-80C 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 & cGMP 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 capacity 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 + 30 days or leave for more than one month.
5.13 The details like calculations chromatograms and strip charts along with comments of manager Quality Control shall be field in training file of analyst.
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 consider as 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 analyst under evaluation, % variation with respect to results of Trainer will be taken for interpretation of the result & % variation should not more than 1%. However, all results of trainer & trainee should comply with the specification.
5.21 The result of analyst should not very by defined acceptance criteria to actual result (test report) of the material.
5.22 Fill the result in analyst validation report (PQ/R/AL/01).
6.0 ABBREVIATIONS

6.1 cGLP Current Good Laboratory Practice.
6.2 cGMP Current Good Manufacturing Practice.
6.3 % Precentage.
6.4 QA Quality Assurance.
6.5 QC Quality Control.
6.6 0C Celcius.
6.7 HPLC High performance liquid chqromatography.
6.8 IR Infrared.
6.8 KF Karl Fisher.
6.9 UV Ualtra violet.

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7.0 ANNEXURES
Annexure

Annexure

LIST OF QUALIFIED ANALYST

Sr. No.

Date

Analyst Name

Code

Qualified On

Next Qualification Due On

Approved By QC/QA

Head (Sign/Date)

Remark