Physical Security And Intactness of Hold and Rejected Material SOP


1.0   PURPOSE:

1.1.      The purpose of this document is to physically secure the hold and rejected materials


2.1.      This procedure is applicable to all Hold and Rejected  materials (Active and In-active) for batch manufacturing at __________ Pharmaceuticals.

3.1.      Store Incharge
3.2.      QC Manager
3.3.      QA Manager
3.4.      QA Officer

4.0    PROCEDURE:

4.1.      All the rejected materials will be immediately shift & kept in Rejected material store.
4.2.      Rejected label (Red colour) will be affixed over this container.
4.3.      The closure of the container will be closed and sealed with appropriate manner like sealing tape etc.
4.4.      The QA officer and QCM will sign the seal.
4.5.      At the time of dispose off  the material, intactness of material will be checked by QA officer and QC Manager.
4.6.      The same procedure will be followed for Hold material which will be kept in Quarantine

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
Rejected Material Intact Certificate.(F-07-020)
FORMAL KPIs (Key Performance Indicators)
Maintaining the record and availability of the record as and when required
GENERAL RISKS
CONTROL   MEASURES

CUSTODIAN
Risks
Impact
Rejected Material has not been destructed properly
Rejected  product may be used/misused
Sealed the container and open the seal in the presence of QA officer and Store Pharmacist
QA Officer
Store Incharge


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