SOP of Cold Chain management in Ware house

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

A cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is use to extend and ensure the shelf life of pharmaceutical product.

Introduction: This document describes procedures to receive Cold chain pharmaceutical materials that will be stored in the warehouse.

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

Responsibility: Receiver, storing, dispatching, record maintaining.                                                                                               

1.0  Receiving of Cold Chain products under the supervision of pharmacist:

The cold chain products 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

·   Lot 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 Note 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 Cold Chain items:

3.1 Pharmacist has to control the temperature and humidity of fridge and controlled area.

·         Store enough frozen icepacks for transportation.

·         Place refrigerators and freezers with space 6 inches away from wall to increase air circulation.

·         Relative humidity need to be actively controlled.

3.2. Common terms for storage

The following terms relate to temperature and medical supplies. It is important to follow the manufacturer’s recommended storage conditions for all products.

·         Store frozen: Some products, such as certain vaccines, need to be transported within a cold chain and stored at -20°C (4°F). Frozen storage is normally for longer-term storage at higher-level facilities.

·         Store at 2°-8°C (36°-46°F): Some products are very heat sensitive but must not be frozen. These are usually kept in the first and second part of the refrigerator (never the freezer). This temperature is appropriate for storing vaccines for a short period of time.

·         Keep cool: Store between 8°-15°C (45°-59°F).

·         Store at room temperature: Store at 15°-25°C (59°-77°F).

·         Store at ambient temperature: Store at the surrounding temperature. It means “room temperature” or normal storage conditions, which means storage in a dry, clean, well ventilated area at room temperatures between 15° to 25°C (59°-77°F) or up to 30°C, depending on climatic conditions.

3.3 Monitoring

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

·          Keep direct sunlight out of the Cold chain area.

·         system able 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)

Racking of Fridge Items;

·   Store all vaccines, Insulin at first and second part of fridge.

·   Rack all drops in door of the fridge.

·   Rack iron supplements, suppositories in door or lower most portion of fridge.

·   Products should be 2-3 inches away from walls.

·   No product touches the fan.

·   First-to-expire first-out (FEFO) have to maintain.

4.0  Dispatch of Cold chain products:

·         Prepare demand carefully and immediately restore it in fridge.

·         Pharmacist must check the proper ice box with ice plates to dispatch the demands.

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

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

·         Stamp the (Dispatched note) of cold chain and controlled items after verification of proper dispatch arrangements.