SUPERVISION
OF ANALYSIS SOPS
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1.0 PURPOSE
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To monitor the analyst activities results accuracy and equipment
performance.
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2.0 SCOPE
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This procedure lays down the general guide line for
supervision of analysis.
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3.0 RESPONSIBILITY
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Ø QC
Manager
Ø QC Assistant Manager
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4.0 PROCEDURE
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Procedure:
1. Spot check once a week all register, reagents and
reference standard solutions.
2. Frequently observe the actual testing done by the
chemist staff.
3. Review analytical report and before signing check
and confirm for:
·
Completeness
of all entries
·
Whether analysis has been
done, and confirm that it has performed as per the specified pharmacopoeia or
in house specification (if specified)
·
If not found to comply, the Assistant
Manager QC should bring to the
attention of the manager quality operations so that necessary action to
rectify/modify the procedure can be taken.
2. Assistant
Manager QC must scrutinize the register
for completeness of all entries to date.
3. Reagents should be stored in bottles.
4. Reference standard solution, working standard stored
in desiccators should be checked for details like name, solvent used wherever
applicable, date of preparation, date of expiry, signature of person preparing.
5. Reagent found to be having sedimentation etc. should
be destroyed and self life period should be reviewed to prevent recurrence.
Assistant Manager QC must observe in person, the work carried out
by the chemist staff so that feedback on the methodology followed, planning of
work, accuracy, precision and efficiency their work can be enhanced.
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5.0 DISTRIBUTION
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Ø Q.A Manager
Ø Q.C Manager