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 the Analytical Division/ Quality Control undergo validation exercises 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 validation by the analyst,
the material with the supplier’s test report (traceable to an authentic testing agency) shall be taken as
the testing material.
Materials already approved by the Analytical
Division, Quality Control, or supplier test report (traceable to an authentic
testing agency) shall be taken as testing material for routine validation
exercises.
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.
The technical / Quality control Manager
will give his recommendation to the 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 the CQA/SOP-004/FR-01 Analyst Validation Report (Appendix I).
The technical Manager / Quality Control Manager
shall give his recommendation to the QA Manager.
QA Manager shall review the validation report
and shall decide on the selection of an 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 the 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 analysis 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 |
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Average |
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Std Deviation |
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% 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:______________________