Report the temperature excursion to the relevant stakeholders, most importantly the Analytical Development and Quality Control (ADQC) staff, as soon as possible and document the events details, such as the date, time, duration, location, and temperature range.
What are temperature excursions in clinical trials?
Temperature Excursion: A temperature reading outside of the acceptable temperature ranges and outside of the acceptable storage temperatures as defined per individual protocol AFTER rounding rules are applied. Investigational product (IP): A new drug or biological drug that is used in a clinical trial.
What is a product temperature excursion issue?
According to European Compliance Academy, a temperature excursion is the deviation from the labelled storage condition of a product for any duration whether during transportation or distribution.
What temperature should a VFC freezer be?
Vaccine Storage Units The freezer must be able to maintain temperatures at or below 5 Fahrenheit (-15 Celsius) and the refrigerator must be able to maintain temperatures consistently between 36 and 46 Fahrenheit (2 to 8 Celsius).
What is considered a temperature excursion?
Any temperature reading outside ranges recommended in the manufacturers package inserts is considered a temperature excursion. Identify temperature excursions quickly and take immediate action to correct them.
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People also ask
What is temperature excursion in pharmacovigilance?
Understanding temperature excursion: A temperature excursion as described by the World Health Organization (WHO) model guidelines is an excursion event in which a Time Temperature-Sensitive Pharmaceutical Product (TTSPP) is exposed to temperatures outside the ranges prescribed for storage and/or transport.
How often should the temperature in the vaccine refrigerator be checked?
Remember, when vaccines get too warm or too cold, you cant tell by looking or feeling if they have been damaged. Thats why its so critical to monitor and record the temperatures inside your refrigerator and freezer at least twice each day to make sure they are within the proper range.
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