Cold Chain Management Guidelines – Philippines

Published by Gabor Szabo on

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In the Philippines, all medical establishments and outlets applying for a license to manufacture, import, distribute or sell vaccines and other biological products have to comply with these requirements.

To be able to get a License to Operate (LTO), all establishments have to be compliant and prove that they are capable of handling vaccines and biological products.

All vaccines need to be stored at the temperature range between +2°C and +8°C (+35°F and +46°F) to ensure they are still in a state where they could be administered safely to patients. Some vaccines are also sensitive to high temperatures, but the lower temperatures affect vaccine potency more than slightly elevated temperatures.

In this article we will focus on the Philippines Cold Chain Management Guidelines for vaccines, but won’t go into details of the universal rules, since most of the vaccine handling rules apply internationally and we have mostly covered them in a previous article for Canada.

The guidelines we will cover are based on the Philippines FDA Cold Chain Management Requirements, BFAD Circular No. 2007-003 documentation.

Regulations for Manufacturers and Distributors

Cold Chain Management

The term “cold chain” is used for the process of maintaining the safe temperature range of +2°C to +8°C (+35°F and +46°F) for vaccines during the transport, storage, and handling. The Cold Chain is starting at the medicine manufacturer and finally ending with the administration of the vaccine to the client.

Facility and Equipment

There are multiple equipment types mentioned in the guidelines, their usage will vary depending on storage or transportation.

Cold room: the appropriate and adequate lighting facilities, with steel racks and/or shelves/pallets (steel, aluminum or plastic) have to be provided. If the cold room will store vaccines, the optimum temperature for refrigeration must need to be maintained between +2°C and +8°C (-13°F and +46°F).

Walk-in Freezer: this can be used by establishments who are dealing with frozen medical products requiring -15°C to -25°C (+5°F and +46°F) only. Similarly, as with a cold room, the appropriate and adequate lighting and storage conditions need to be present.

Biological or pharmaceutical refrigerator: this can be used by establishments who are having minimal stock of vaccines and biological products only. The optimum temperature for refrigeration must be maintained between +2°C and +8°C (+35°F and +46°F).

For storage equipment, the usage of a generator set and Voltage Stabilizers (Automatic Voltage Regulator) is highly recommended.

Ice Packs, Cold Box or Transport Box and Cold Transport Vehicle have to be used when the vaccines are moved, to ensure the safe temperatures are maintained.

Cold Chain Monitoring Tools

Vaccines and other biological products must be constantly monitored during the Cold Chain. Commercially available and approved Vaccine Cold Chain Monitors and Vaccine Vial Monitors must be used. To protect the vaccines from freezing, Freeze Watch Indicators should be installed.

For monitoring temperatures, a minimum of two thermometers must be used, and they have to be recalibrated at least twice per each year.

Temperature alarm systems should be installed to warn personnel when the temperature range goes outside of the limit.

The temperature monitoring and recording of temperatures in cold rooms and freezer-rooms has to be done at least twice a day, seven (7) days a week and any of the following devices can be used:

  • Analog pen recorders
  • Digital recording system by using sensor equipment
  • Manual monitoring chart which is supervised by technical personnel

Personnel

For all medical and non-medical personnel involved in the Cold Chain, they must show proof of attendance to any credible training or seminar regarding Cold Chain management, as determined by BFAD rules.

They must understand their duties and responsibilities, and wear protective work clothing accessories such as warm clothing or jackets, trousers, gloves and boots (this is mostly for establishments having a cold room and walk-in freezer).

Documentary Requirements

Documented procedures have to be in place for various conditions:

Make a contingency plan for both mechanical and power failures, and cold chain emergencies.

Have the certificate/s of calibration of all temperature monitoring devices on hand.

Standard Operating Procedures (SOPs) need to be defined about the following: 

  • Maintenance and care of the facility and its equipment (cold room, walk-in freezer, chiller, biological or pharmaceutical refrigerator, ice pack freezer)
  • Monitoring and adjusting the temperature of the facility and its equipment (cold room, walk-in freezer, chiller, biological or pharmaceutical refrigerator, ice pack freezer)
  • Cold chain procedures that are employed from the country of origin, port of entry, and up to the outlets
  • Procedures for temperature mapping
  • Procedures for the freezing of ice packs
  • Maintaining the correct temperature in cold boxes or transport boxes, and the vaccine carriers including validation studies
  • Procedures for stacking vaccines and biological products in the cold room or walk-in freezer
  • Procedures for the loading of vaccine into cold boxes or transport boxes, and into vaccine carriers
  • Procedures for handling product complaints and product recalls
  • The proper destruction of expired/damaged/recalled vaccines and biological products
  • Emergency and safety measures in case of breakage in the Cold Chain or other incident that may arise during handling and storage

The records and logs of the following have to be kept: 

  • Temperature mapping logs
  • Validation studies for Cold Chain compliance during transport, and for the freezing and thawing time of ice packs
  • Product recalls and complaints, including the status and the actions taken

Regulations for Retail Drug Outlets

The regulations for Retail Drug Outlets are similar as to the Manufacturers and Distributors.

Facility and Equipment

Biological or pharmaceutical refrigerator: this must be a dedicated unit for vaccine, biologicals and other drug products requiring cold storage. The optimum temperature for refrigeration must be maintained between +2°C and +8°C (+35°F and +46°F).

Freezer or a domestic refrigerator with freezer can be used only for the ice, which is used in dispensing vaccines.

For storage equipment, the usage of a generator set and Voltage Stabilizers (Automatic Voltage Regulator) is highly recommended.

Cold Chain Monitoring Tools

Any vaccines and other biological products must be constantly monitored during the Cold Chain, even if they are delivered to a pharmacy.

For monitoring temperatures, a minimum of two thermometers must be used, and they have to be recalibrated at least twice per each year.

Temperature alarm systems should be installed to warn personnel when the temperature range goes outside of the limit.

The temperature monitoring and recording of temperatures has to be done at least twice a day, seven (7) days a week and any of the following devices can be used:

  • Digital recording system by using sensor equipment (if applicable)
  • Manual monitoring chart which is supervised by the pharmacist or any technical personnel

Personnel

For all medical and non-medical personnel involved in the Cold Chain, they must show proof of attendance to any credible training or seminar regarding Cold Chain management, as determined by BFAD rules.

They must understand their duties and responsibilities, and act immediately if a Cold Chain breach has been identified.

Documentary Requirements

Documented procedures have to be in place for various conditions:

Make a contingency plan for both mechanical and power failures, and cold chain emergencies.

It is also very important that a contingency plan in case of cold chain emergency has to be put in place.

Have the certificate/s of calibration of all temperature monitoring devices on hand.

The Standard Operating Procedures (SOPs) need to be defined about the following: 

  • Maintenance and care of the biological or pharmaceutical refrigerator / chiller/ freezer
  • Monitoring and adjusting the temperature of the biological or pharmaceutical refrigerator / chiller/ freezer
  • Cold chain procedures that are employed in dispensing
  • Procedures for stacking vaccines and biological products in the pharmaceutical refrigerator / chiller/ freezer
  • Procedures for the loading of vaccine into cold boxes or transport boxes, and into vaccine carriers
  • Procedures for handling product complaints and product recalls
  • Emergency and safety measures in case of breakage in the Cold Chain or other incident that may arise during handling and storage

The records and logs of the following have to be kept: 

  • Temperature mapping logs
  • Product recalls and complaints, including the status and the actions taken

Conclusion

In this article we have covered the Philippines Cold Chain Management Guidelines for vaccines, based on the Philippines FDA Cold Chain Management Requirements, BFAD Circular No. 2007-003 documentation.

The License to Operate (LTO) will be issued based on the compliance to these guidelines.

As a general rule, it is important to always monitor the temperatures of vaccines, which needs to be between +2°C and +8°C to ensure they are still in a state where they could be administered safely to patients.


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