IN-PROCESS MATERIAL HANDING SOPS

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