Site icon Pharma Dekho

sop for performance qualification for analyst

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

.
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

process validation protocol for methylcobalamin niacinamide and pyridoxine injection

validation protocol of sterility test

sop for Analytical Method Transfer

Protocol for hold time study of sterile garments

sop for process validation

sop for swab sampling for validation of clean surfaces

cleaning validation maco and noel calculation formula

sop for performance qualification for analyst

Sop for Validation report for disinfectant efficacy

Sop for Method validation report for bacterial endotoxin test

Sop for method validation microbiology sterility testing

sop for validation report for preservative efficacy test

sop for Protocol cum report for efficacy qualification of uv light

sop for validation protocol for uv light efficacy of dpb & laf

sop for cleaning validation protocol tablet manufacturing equipment

sop for cleaning validation protocol ointment manufacturing equipment

concurrent process validation for rabeprazole ec and domperidone sr capsules

sop for Validation for cleaning procedure liquid injection

sop for Validation for cleaning procedure dry powder injection

sop for validation plan

Protocol for re validation of dry heat sterilizer

Exit mobile version