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1.0
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PURPOSE
To lay down a procedure for the sampling &
handling of bulk sample.
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2.0
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SCOPE
This procedure is applicable to the sampling &
handling of bulk sample in manufacturing area.
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3.0
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RESPONSIBILITY
IPQA chemist
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4.0
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ACCOUNTABILITY
Head Quality Assurance.
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5.0
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
5.11
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PROCEDURE
The production personnel
shall submit a requisition slip ‘Requisition For Sampling And Testing’ to the
In process Quality Assurance personnel deputed at the production floor, for
the sampling of bulk.
The sample shall be collected directly by
the IPQA personnel.
IPQA personnel shall affix
a status label on the container (double polythene bag for solid samples and
glass bottle plastic bottles for liquid samples) in which sample is to be
collected. The label shall bear sample name, batch no. /Lot
no. (if any), Batch size, date of sampling, container number and
signature.
Before withdrawing sample, ensure that all
the bulk containers are labeled with required information.
Solid sample (such as
granules) shall be collected with a clean sampling rod, and liquid samples
shall be collected from the sampling port (wherever provided).The withdrawn
sample shall be transferred into the labeled container.
The quantity of bulk
samples for products shall be
collected as follows:
Tablet - 20 gm
Liquid
Oral - 100 ml
Lotion
& cream -100 gm
Soap - 50 gm
Ensure that samples are
collected from top, middle and the bottom of the containers to maintain the
homogeneity.
Close the container
properly after withdrawing sample.
Label the polybags or
container with the labels and transfer to quality control laboratory for
analysis.
Sample shall be sent to QC
for analysis.
Generate the A.R. no. in
computer, and test report in duplicate duly signed and approved by
appropriate personnel, send one copy to Section In charge another with
worksheet along with chromatogram graph, spectra if applicable duly signed
for reference and record.
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6.0
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REFERENCES
SOP guideline by D.H. Shah
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7.0
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ANNEXURES
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Annexure No.
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Title of Annexure
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Format No.
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Nil
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8.0
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ABBREVIATIONS
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Abbreviations
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Full Forms
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SOP
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Standard Operating
Procedure
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QA
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Quality Assurance
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QC
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Quality control
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IPQA
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In Process Quality
Assurance
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9.0
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DISTRIBUTION
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Master Copy
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Head Quality Assurance
Department
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Controlled office Copy No. 1
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Head Quality Assurance Deptt.
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Controlled office Copy No. 2
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Head Production (Tablet) Deptt.
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Controlled office Copy No. 3
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Head Production (Liquid)
Deptt
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Controlled office Copy No. 4
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Head Production (External)
Deptt
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Controlled office Copy No. 5
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Head Production (Soap)
Deptt
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10.0
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REVISION
HISTORY
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S.No.
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Revision No.
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Effective
Date
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Reason for
Revision
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Details of
Change
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Authorized
By
(sign
& Date)
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