Physical Security And Intactness of Dispensed Material SOP
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1.0
PURPOSE:
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1.1. The purpose of this document is to physically secure
the dispensed raw materials for batch manufacturing
2.1. This
procedure is applicable to all dispensed materials (Active and In-active) for
batch manufacturing at _____________Pharmaceuticals.
3.1. Store Incharge
3.2. QA Officer
3.3. QA Manager
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4.0
PROCEDURE:
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All
the dispensed materials will be kept in Main dispensed material container.
A
label will be affixed over this container indicating the Product and B. No. for
which the material is dispensed.
The
closure of the container will be closed and sealed with appropriate manner like
sealing tape etc.
The
QA officer and RMS officer will sign the seal.
At
the time of receipt by production, confirmation will be made that material is
intact at the time of receipt. RMS officer and Production representative will
sign the “Material Intact Certificate (F-07-017)”
At
the time of start of batch manufacturing, material integrity will again be
checked by production representative and will be verified by QA officer on
“Material Intact Certificate (F-07-017)”
The
same procedure will be followed for printed packing material. (F-07-017).
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5.0
Intact
Definition:
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5.1. If something
is intact it's still in one piece.
5.2. Here we mean
that all the seals and sign are in original form without any tempering. When
the material is found Intact, it will be considered physically secured.
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EVIDENCES OF RECORDS & REFERENCES
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Material Intact Certificate.(F-07-017)
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FORMAL KPIs (Key Performance Indicators)
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Maintaining the record and availability of the
record as and when required
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GENERAL RISKS
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CONTROL MEASURES
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CUSTODIAN
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Risks
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Impact
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Mix up of materials of 2 or more products.
for e-g:
unit carton of
EVOLET 250mg or EVOLET 500mg.
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Any problem in Batch occurs
i-e Evolet 250 mg Packed in Batch no of Evolet 500mg .
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Sealed the container and open the seal in the presence of
QA officer and Store Pharmacist
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QA Officer
Store Incharge
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