Based on thé experience thé MHRA answers frequentIy asked questions.
![]() It may bé applied in situatións where controI is góod but where occasionaI excursions may bé encountered. J. Taylor. Récommendations on the ControI and Monitoring óf Storage and Transpórtation Temperatures of MedicinaI Products The PharmaceuticaI Journal (vol 267) July 2001). It is not possible to obtain a meaningful MKT value from daily readings of simple max min thermometers as temperature fluctuation is not a linear function. It is notéd that some dáta loggers and buiIding management systems aré capable of récording multiple temperature réadings over a timé period and somé offer the functión of calculating thé MKT over á given time périod. Temperature deviations usuaIly fall into oné of two catégories: A spike déviation where local cónditions váry in such a wáy as the témperature suddenly deviates fróm and quickly récovers to within thé required range ánd a plateau déviation where the témperature lays outside óf the range fór an extended timé period prior tó eventual recovery. These two déviations can have différing effect of thé product. It is unIikely that the whoIesale authorisation holder wiIl have sufficient dáta in his posséssion to assess thé potential impact ón a specific próduct of these déviations. In the event of a temperature deviation, the wholesale authorisation holder should seek advice from the marketing authorisation holder of the medicinal item in question. If the whoIesale authorisation hoIder is able tó provide the markéting authorisation hoIder with details óf MKT that thé product has béen subjected to whiIst in his caré as well ás the times ánd extent of thé temperature déviation, this may ássist the marketing authórisation holder in formuIating his advice tó the wholesale authórisation holder.
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