For handing of intermediate and finished goods this SOP "In Process Material Handing" is created.
In Process Material Handing Sop PURPOSE
To ensure proper transfer of intermediate / finished bulk from production to stores, from stores to packing and prevent mix-up of material.
SCOPE
This procedure applies to Production, Intermediate storeroom and packaging.
RESPONSIBILITY
Production Supervisor
Packaging Supervisor
PROCEDURE
When a batch of intermediate / finished bulk (e.g. Granulation / capsules, bottles, vials) is manufactured, it is transferred to “Quarantine Area”
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.
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.
The container is clean and tidy inside and outside and container does not have label of previous batch.
The containers are weighed in presence of production supervisor and packaging supervisor.
When the material is approved by Q.C., it is then transferred safely to the designated area as requisitioned.
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.
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.
Glass Bottles & Caps after cleaning should be transferred in trays or safe container to avoid breakage & contamination during handling.
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.
DISTRIBUTION
- Head of Operation
- Q.A Manager
- Production Manager
- Q.C Manager
- Production Pharmacist