Standard Operating Procedure – Drug Distributor: Cold Chain Procedure

(Header as exampled by FDA)

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Objective:

• To ensure that proper storage of drugs is strictly observed.
• Provide proper equipment that will maintain the stability and efficacy of drugs.
• Unbroken temperature storage, maybe transit or shipment, must be achieved.

Scope:

• All drugs products, especially biological, vaccines and other drugs, under special temperature condition.

Responsibility:

• Pharmacist
• Personnel
• Forwarder

Procedure:

1. Pharmaceutical Refrigerator/Chiller/Freezers

• Strictly requirement and implemented for vaccines, biological and drug products under cold storage condition.
• Monitoring of temperature range and observed cleanliness.
• Must be organized and icepack when dispensing or delivering.

2. Temperature

• The thermometer must be calibrated and minimum of two thermometers are needed. Calibration must be done twice a year.
• Read the thermometer at least twice daily. Probably, morning and afternoon are the appropriate time or when the peak of the heat is to prevent spoilage of vaccines and biological products
• Have temperature monitoring chart and should be accomplished by the pharmacist or personnel
• Monitor the room temperature twice a day too.

3. Dispensing

• If the customer's location is far away, ice pack should be attached.
• The drugs must be dispensed under regulated and desired temperature condition.

4. Stocking

• Should be organized.
• If needed, use some plastic containers or plastic wares to maintain the good appearance of the box and freshness of the product.

5. Emergency and Safety measures

• Delivered products from company to the store should be closely monitored as to maker, specifications and most importantly the expiration dates of each products to ensure the safety and welfare of the end users.
• In case of refrigerated drugs are accidentally break such as ampules/vials, broken pieces should be cleaned and the person clearing it must be careful.
• When power-interruption is occurred, electric generator should be utilized to sustain the ranged temperature of the drug products, especially the biological and vaccines.

6. Product Returned or Complaint

• The product must be in proper temperature storage before returning it.
• If ever the product is not in well-monitored temperature and storage, the acceptance of the returning drug will be denied.
• In case the cold chain is maintained, ask for the receipt and do the necessary action to make.

7. Product Recall

• In the event that product complaints arises, customers are advised to return the product with the accompanying receipt for proper inspection and cold chain should be maintained as the the veracity of the complaints.

Quality of Record:

• Systematic actions necessary to ensure adequate confidence that the product and documentation will satisfy the requirements for quality assurance.
• Temperature monitoring chart should be checked frequently to sustain the stability of the drug.

Form:

• Temperature Monitoring Sheet
• Logbook

End of Document