1.0 Objective:
To
provide a procedure for establishing the capability of an analyst to perform
analysis accurately.
2.0 Scope:
This
SOP covers qualification and validation of an analyst .
3.0 Responsibility:
Department
Head: Provide necessary training to analyst and give coded sample for analysis.
General Manager: Evaluate the
data of analysis results.
QA Manager: Review the records
and governing the document.
4.0 Procedure:
4.1 QUALIFICATION
OF AN ANALYST
4.1.1 Ensure that every new analyst (both fresh and experienced)
works with the senior at least for two days.
4.1.2 The senior analyst shall explain all aspects of the analysis
from sample staging to reporting the results.
4.1.3 Give previously approved sample (Coded sample) to the new
analyst for analysis.
4.1.4 Evaluate analysed values for the following tests: Assay,
Moisture content / Loss on drying, Identification by FTIR / UV.
4.1.5 The results of analysis shall meet the requirements
(acceptance criteria).
4.1.6 The analytical report shall be verified with the previous
results by the GM.
4.1.7 If the
result does not meets the acceptance criteria, the Department Head shall
parallel analyse the sample with the analyst to assess the errors and impart
the necessary training to improve his/her skills.
4.2 VALIDATION
OF AN ANALYST
4.2.1 The validation of an
experienced analyst shall include one or more of the following tests.
4.2.1.1 Assay
4.2.1.2 Moisture content by KF / Loss on drying
4.2.1.3 Melting point
4.2.1.4 Identification by FTIR, Ultra Violet /
Visible Spectrophotometer.
4.3 The validation shall include one or
more of the following methods:
4.3.1 HPLC / GC
4.3.2 Ultra Violet / Visible Spectrophotometer
4.3.3 Titrimetry
4.3.4 Karl Fischer
4.3.5 Melting point determination
4.3.6 Infra-Red analysis
4.4 Identify samples known analytical
values and code the same. QA Officer shall do this.
4.5 Record the analytical value/s of
sample/s along with acceptable limits, A.R. No.
4.6 The result of the analysis by the
analyst under validation shall be checked for cGLP compliance and compared with
expected values.
4.7 The capability to perform the analysis
by the analyst shall be considered satisfactory if the results reported by the
analyst are within the acceptable limits.
4.8 The raw data of analyst validation including
worksheets, calculations, chromatograms, and strip charts along with comments
of QA Officer shall be filed in Analyst validation file.
5.0 Documentation:
5.1
Annexure – 1 Analyst validation Register: XXX/SOP/000
Annexure – 2 Acceptance criteria : XXX/SOP/000
6.0 History of Revision:
Revision No.
|
Effective
Date
|
Revision
details
|
Reason for
revision
|
Annexure – 1
Sr. No.
|
Name of the Analyst
|
Validated
for
|
Code no
of
Sample
|
Acceptable
Limits
|
A.R. No.
|
Analysis Date
|
Date of
Completion
|
Remarks
|
Checked by
|
Annexure – 2
Acceptance Criteria |
|||||||||||
Sr. No.
|
Tests
|
Acceptance Criteria
|
|||||||||
1
2
3
4
5
6
7
|
± 0.5 % of the
Initial value
± 0.5 % of the
Initial value
± 0.5 % of the
Initial value
± 0.5 % of the
Initial value
Should be
comparable
Within
range and comparable with earlier results
To
be decided on case to case basis by GM or QA
|
||||||||||
SOP No. : XXX/SOP/000
|
|||||||||||
No comments:
Post a Comment