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Having detailed the principal problems encountered by pharmaceutical laboratories, Annick Demouy, Quality Assurance Pharmacist at Laboratoires Stradis, tells us more about transporting heat-sensitive medicines via the cold chain.
This is a statutory requirement. The medicine must satisfy every criterion of the specifications described in its MA (Marketing Authorisation) dossier. In the case of chilled products, the most frequently defined temperature range is between +2 and +8 °C.
This temperature range has been defined by stability
tests conducted during the development phase of the medicines, which are
specified on the basis of:
Stress tests and accelerated tests are used to assess the risk of deterioration of a product in the event of deviation from the ideal storage conditions.
Temperature fluctuations (heat or cold) can adversely affect the reliability of the medicine and, in turn, public health. A medicine can deteriorate physically and chemically or it may prove to be contaminated at the microbiological level. It may lose its effectiveness or, even worse, it may become toxic. Deterioration of a medicine is seldom visible but the risk is just as high.
These two terms are not synonymous. Temperature excursion is a deviation but the reverse is not correct: a temperature deviation is not always a temperature excursion.
Excursion beyond the temperature range is a deviation and should be treated as such, regardless of the duration of the excursion. It is necessary to evaluate the potential impact on the quality, effectiveness and safety of the medicine. This evaluation is based on the field of knowledge of the medicine and on its stability studies. It is conducted by the person responsible at the pharmacy, at the manufacturer, at the hospital or at the dispensary, who is then called upon to reach a decision. The correct decision is the one that does not incur any risk to public health: the safety of the patient takes precedence over all other considerations!