SOP for Receipt, Storage and Issue of Bulk Tablets in Tablet Storage Area

OBJECTIVE

To provide a procedure for Receipt, Storage, and Issue of Bulk/Unpacked tablets in the Tablet storage area.

To have proper accountability and control of Bulk tablets in the Tablet storage area.

SCOPE

It is applicable to the Tablet storage area located in the Production department.

RESPONSIBILITY

• Designated person / Custodian: To receive, store, and issue the bulk tablets as per this SOP and maintain a record for the same as per Attachment-1.
• Production Supervisor: To monitor the activities of the Designated person and cross-check records maintained for the movement of bulk tablets in and out of the Tablet storage area.
• Production Manager / QA Manager: To ensure that the SOP is followed.

PROCEDURE

Receipt

• The Designated person shall collect the drums of Bulk tablets coming from the Compression area to store in the tablet storage area.
• The Designated person shall weigh the individual incoming drums and cross-check the values of the weight of drums as indicated on the drum label and respective product BMR. If there is any discrepancy, the Production Supervisor shall be informed and necessary action shall be taken.

• Receipt of drums shall be recorded in the register by the Designated person as per Attachment-1: ‘Format of Unpacked tablets receipt and issue register’.

Storage

• The Designated person shall store the incoming tablet drums in their respective area batch-wise, that is, either in the ‘QUARANTINE’ area or ‘RELEASED’ area as per the status of the drums. A yellow-colored rope shall be used to separate the ‘QUARANTINE’ tablets area from the ‘RELEASED’ tablets area within the Tablets Storage room.
• Preferably, only one batch shall be stored on one pallet in order to achieve both product-wise and batch-wise segregation of tablets.
• The tablet drums shall be kept closed using lids.
• Interim storage of the tablets in bulk containers should generally not exceed six months

ALSO READ: SOP for Disposal of Tablets and Capsules after In-Process Checks

Issue

• Upon request of the Packaging department, the Custodian shall issue the Bulk tablets to packaging personnel under the supervision of the Production Supervisor.
• The details of the issue shall be recorded in the register as per Attachment-1: ‘Format of Unpacked tablets receipt and issue register’.
• The Packaging personnel shall weigh the tablets drums individually and record the same in the respective product BPR. The weights shall match the values indicated on the drum label. If there is any discrepancy, QA Manager and Production Manager shall be informed and necessary action shall be taken.
• The signature of the Packaging personnel shall be taken in the register after issuing the requested tablet drums, by the Designated person. The Production Supervisor observing the issue activity shall also sign under the ‘Checked by’ column of the register.

ATTACHMENTS

Attachment-1: Format of Unpacked tablets receipt and issue register.

ABBREVIATIONS

SOP: Standard Operating Procedure.

QA: Quality Assurance.

BMR: Batch Manufacturing Record.

BPR: Batch Packaging Record.

REVISION HISTORY

Nil

ALSO READ: SOP for Operation and Cleaning of Tablet/Capsule Counting Machine