FAQ: drug temperature requirements

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In order to conduct a successful drug trial, it is important to precisely follow all drug handling guidelines. During the latest COREX Academy webinar, we discussed various questions related to the transportation process and drug storage requirements that the clinical research sites must follow. In this Q&A, we’ve compiled the most important and popular questions specifically about temperature requirements.

 

Q: What is the best way to guarantee the quality of any clinical trial drug? 

A: Temperature control is essential to ensure the drug’s quality.

 

Q: Can the transportation and storage of drugs and biosamples be conducted without any temperature control? 

A: No, it is necessary to control the temperature during both transportation and storage processes. 

 

Q: When the drug is being received at a clinical research site, what are the factors that can affect the stability of the drug’s temperature?

A: The distance from the front desk to the refrigerator and the means of its transportation on-site can affect the temperature and the preservation of the drug.

 

Q: During receipt of the drug at a clinical research site, when do the thermostat’s readings have to be taken? 

A: The readings have to be taken exactly at the time of the container’s opening. 

 

Q: Why is it important to note the exact time of the container’s opening at the clinical research site?

A: It is important to have a clear chain of the temperature conditions throughout the drug’s storage.

 

Q: Is it necessary to monitor the temperature during the drug’s transportation around the clinical research site?

A: Yes, it is always necessary to monitor the temperature of the drug during any transportation in order to exclude any possibility of temperature variation. 

 

Q: How are the acceptable limits of the temperature variation defined? 

A: The acceptable limits can be only defined based on the information provided by the sponsor.

 

Q: Can any transportation inside the clinical research site be considered a variation if it is performed outside of the temperature limits?

A: Yes, any transportation outside of the provided temperature limits is considered a variation. For example, the temperature can rise if the drug is carried in hands or if it stays outside of a refrigerator for too long. 

 

Q: Are the researchers allowed to suggest the acceptable temperature variation outside the limits suggested by the sponsor?

A: No, they can only use the guidelines provided by the sponsor. 

 

Q: Who is responsible for the evaluation of the temperature disruption?

A: Only the trial’s sponsor can perform the evaluation. 

 

Q: Is it important to control the temperature during the mixing and administration of the test drug?

A: If not stated in a separate document provided by the sponsor, the temperature is not controlled during said procedures, they are usually performed at room temperature. 

 

Q: What does the term room temperature usually mean in relation to drug storage?

A: The term room temperature is defined differently in different pharmacopoeias, the average room temperature is between 15C and 30C.

 

Q: What are the main drug and biomaterial storage temperature regimes?

A: There are three main regimes: the 2-8℃ regime, the 15-25℃ regime and the room temperature regime.

 

Q: How often is it necessary to take temperature readings of the drug during its storage at the clinical research site?

A: It is important to continuously control the temperature of the drug. 

 

Q: Can a regular refrigerator be used to store drugs and biomaterials?

A: No, only a specialised medical refrigerator can be used for the storage of drugs and biomaterials. 

 

Q: Can a thermostat located outside of the refrigerator be considered a storage temperature sensor?

A: No, the thermostat must be located inside the refrigerator. 

 

Q: What is the best amount of temperature sensors per one storage unit?

A: It is best to have at least two sensors per any storage unit to have two readings each time in case one of the sensors fails.

 

Q: Who is responsible for the drug’s temperature during its storage at a clinical research site?

A: The facility’s personnel are responsible for the drug’s temperature throughout its presence at the site.

 

Q: When only the upper temperature limit is indicated for a drug, does this mean that it can be stored at any temperature below this limit, even at negative temperature?

A: No. Usually, when only the upper limit is indicated, it means that the lower limit is +2℃ by default.

 

Q: Who is responsible for the temperature sensors and their efficacy?

A: The clinical research site is responsible for everything related to the sensors.

 

Q: Is it necessary to take temperature readings every day, including the weekends and the holidays?

A: Yes, it is absolutely necessary to take readings every day.

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