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SOP for Receipt, Storage and Handling of Controlled Substances

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

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

  • 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.

  • 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 delivery note or invoice 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 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 Pharmacist.

SOP: Standard Operating Procedure.


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