IN-PROCESS
MATERIAL HANDING SOPS
1.0 PURPOSE
|
To ensure proper
transfer of intermediate / finished bulk from production to stores, from stores
to packing and prevent mix-up of material.
2.0 SCOPE
|
This procedure applies to
Production, Intermediate storeroom and packaging.
3.0 RESPONSIBILITY
|
Ø Production
Supervisor
Ø Packaging
Supervisor
4.0 PROCEDURE
|
Ø When
a batch of intermediate / finished bulk (e.g. Granulation / capsules, bottles,
vials) is manufactured, it is transferred to “Quarantine Area”
Ø Production
Supervisor ensures that each container of the transferring material has status
label for the content on the container and not on the lid. A duplicate label is
also affixed on polythene bag inside container.
Ø The
bulk material is packed in double polythene bags and bags are sealed (Knotted
properly in case of oral solid dosage forms) in boxes or shipping cartons for
injectables.
Ø The
container is clean and tidy inside and outside and container does not have label
of previous batch.
Ø The
containers are weighed in presence of production supervisor and packaging
supervisor.
Ø When
the material is approved by Q.C., it is then transferred safely to the
designated area as requisitioned.
Ø In
case intermediate batches which require further processing (e.g. coating) it is
transferred to production area where they are checked to confirm content
identity and QC approval before processing.
Ø The
finished product batch on QC approval is transferred to holding area or to
packaging hall for packing. The line Incharge / packaging supervisors’ checks
identity of product, batch no., number of containers and quantity of batch
before starting packaging operation.
Ø Glass
Bottles & Caps after cleaning should be transferred in trays or safe
container to avoid breakage & contamination during handling.
Ø When
Packaging Material (label or carton) is rejected due to misprint or not legible
over print or carton torn up during processing the material is scrapped, number
of rejects recorded & material reissued on QC authorization.
5.0 QUALITY FORMS AND RECORDS
|
N/A
6.0 DISTRIBUTION
|
Ø Head of Operation
Ø Q.A Manager
Ø Production Manager
Ø Q.C Manager
Ø Production Pharmacist
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