SOP for Receipt, Storage and Handling of Controlled Substances

OBJECTIVE

To provide a procedure for the receipt, storage and handling of controlled substances.

SCOPE

It applies to the receipt, storage and handling of controlled substances at XYZ Limited.

RESPONSIBILITY

• It is the responsibility of the Production Pharmacist to receive, store and handle the controlled substances as per this SOP.
• It is the responsibility of QA Manager to ensure that the procedure is followed.

PROCEDURE

• The controlled substances shall be received at the receiving bay.
• De-dust the containers containing controlled substances as per SOP ‘De-dusting of containers on receipt and storage’.
• Security personnel and Warehouse personnel must check for the accuracy of quantities on the delivery notes or invoices with the physical quantity, under the supervision of the Pharmacist.
• The documentation for receipt of controlled substances shall be done as per SOP for Receipt and Storage of Raw Materials.
• The controlled substances shall then be stored in the designated room under lock and key. The key for the room shall remain with the Pharmacist.
• The sampling, dispensing and issuing of controlled substances for production use shall be performed under the supervision of a Pharmacist.
• The granulation, drying, mixing, compression and packing activities during the formulation of controlled substances should be done under the direct personal supervision of the Pharmacist.
• The compressed naked tablets of controlled substances before commencing the packing activity shall be kept under lock and key.
• Record for accountability during manufacturing and packing activity shall be maintained.
• The distribution record for finished products of controlled substances shall be maintained and the transfer of these finished products out of the factory premises shall be authorized by the Pharmacist.

ABBREVIATIONS

SOP: Standard Operating Procedure.

REVISION HISTORY

Nil

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