SOP for Pharmaceutical Warehouse

Standard Operating Procedure (SOP)
Title	Central Warehouse
QA Signature		Area Manager Signature
Date of signature		Date of signature

Introduction: This document describes procedures to receive Surgical, pharmaceutical, consumer materials that will be stored in the warehouse.

Objective: To receive and dispatch the Surgical, pharmaceutical, consumer vaccines and biological products.

Responsibility: Receiver, storing, dispatching, record maintaining.                                                                                               

      1.0  Receiving of Stock under the supervision of pharmacist:

The stock will:

1.1  Inspect all incoming vehicles by pharmacist for the following:

·         Trucks should have controlled temperature

·         Floor boards are dry and clean.

·         Humidity should be controlled.

·         No bad odor.

1.2  Unload the shipment and inspect the condition of the shipment to ensure:

·         No damaged cases or packages.

·         On receipt of wet and damaged goods.

·         No receiving of cold products without ice plates.

1.3  Check the drivers slip to ensure the company states.

1.4  Count the goods and compare the

·         Quantity, name, expiry and lot numbers to the information stated on the shipping documents and company invoice order (IO).

·         No receiving of cold chain items if they are not in proper medical cold chain box.

·         Items must be in dry and good packaging condition.

·         No receiving in case of leakage or physically unstable packaging.

·         Investigate any discrepancies.

·         Immediately transfer the stock to Cold chain area.

1.5  Complete the “Receiving Log” under pharmacist supervision with the following information:

Product Information:

·   Received date

·   IO number

·   Expiry date

·   Reg. number

·   Invoice No.

·   Quantity received

·   Shipment Supplier

·   Shipment Carrier

Vehicle Inspection:

·   Visual inspection

·   Temperature monitoring

·   Clean and dry vehicle space

·   Odor inspection

·   Pest / Rodent activity

·   Vehicle number

Note:

1.6     Once Pharmacist has approved receiving store product in the specific cold chain area.

2.0  Receiving of products at Cold chain /Card area:

·   Cold chain items received by only cold chain supervisor.

·   Count and recheck by invoice.

·   Save the invoice copy of cold and card items.

·   Immediately store in fridge according to their temperature requirements.

Pharmacist must check temperature, quality, registration and proper receiving of items under his supervision and sign on Purchase order for approval.

      3.0  Racking and maintenance of items:

·         Pharmaceutical products should be stored off the floor. Pallets should be kept in a good state of cleanliness and repair.

·         Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and access restricted to authorized personnel.

·         Physical or other equivalent validated (e.g. electronic) segregation should be provided for the storage of rejected, expired, recalled or returned products and suspected counterfeits.

·         Pharmaceutical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination.

·         A system should be in place to ensure that the pharmaceutical products due to expire first in first out (first expiry/ first out (FEFO)).

·         Broken or damaged items should be withdrawn from usable stock and stored separately.

·         Relative humidity need to be actively controlled.

3.3 Monitoring

·         Pharmacist has to monitor and maintain temperature and humidity record on daily bases.

·          Keep direct sunlight out of the Storage area.

·         System continuously to maintain air temperatures within the set point limits throughout the validated storage volume

·         control sensors calibrated and accurate to ± 0.5 °C or better

·         Keep the record maintain from Pegasus(temperature data lodger)

         4.0  Dispatch of Stock:

·         Prepare demand carefully as per STR via picker.

·         Check the STR and hand over the demand to supply man.

·         Pharmacist should dispatch all cold chain products under his supervision.

·         Pharmacist should check the vehicle temperature and all medicines should be on pallet.