Physical Security And Intactness of Dispensed Material SOP


1.0   PURPOSE:

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

4.0    PROCEDURE:

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).

5.0     Intact Definition:

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.



EVIDENCES OF RECORDS & REFERENCES
Material Intact Certificate.(F-07-017)
FORMAL KPIs (Key Performance Indicators)
Maintaining the record and availability of the record as and when required
GENERAL RISKS
CONTROL   MEASURES

CUSTODIAN
Risks
Impact
Mix up of materials of 2 or more products.
for e-g:
unit carton of  EVOLET 250mg or EVOLET 500mg.
Any problem in Batch occurs
i-e Evolet 250 mg Packed in Batch no of  Evolet 500mg .
Sealed the container and open the seal in the presence of QA officer and Store Pharmacist
QA Officer
Store Incharge


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