MKT值应该如何评价药品质量？

Stargazer_Stead

请问各位大师， 计算出MKT 值后 这个值应该怎样判断 ，如运输2-8度商品，途中低了或高了， 计算出来的值为5.5  有质量影响吗？没有影响有怎么解析？如计算出来的值为13，哪有如何解析和评价药品的质量。{:soso_e132:}

volador

https://www.ouryao.com/forum.php?mod=viewthread&tid=243038

罗伊鲱

GDP Question: When to use Mean Kinetic Temperature Calculation (MKT)?
07/05/2014

The British Medicines Authority MHRA is performing GMP and GDP Inspections on a risk based strategy. Based on the experience the MHRA answers frequently asked questions. One very interesting Q&A refers to Mean Kinetic Temperature Calculations (MKT). Mean kinetic temperature is a simplified way of expressing the overall effect of temperature fluctuations during storage or transit of perishable goods. The MKT is widely used in the pharmaceutical industry. According to Pharmacopeia definition the MKT "is defined as the single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures."

According to MHRA: "Mean Kinetic Temperature (MKT) should not be used to compensate for poor temperature control of storage (or transportation) facilities. It may be applied in situations where control is good but where occasional excursions may be encountered. (J. Taylor. ‘Recommendations on the Control and Monitoring of Storage and Transportation Temperatures of Medicinal Products’ The Pharmaceutical 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 noted that some data loggers and building management systems are capable of recording multiple temperature readings over a time period and some offer the function of calculating the MKT over a given time period.

Temperature deviations usually fall into one of two categories: A ‘spike’ deviation where local conditions vary in such a way as the temperature suddenly deviates from and quickly recovers to within the required range and a ‘plateau’ deviation where the temperature lays outside of the range for an extended time period prior to eventual recovery. These two deviations can have differing effect of the product.

It is unlikely that the wholesale authorisation holder will have sufficient data in his possession to assess the potential impact on a specific product of these deviations. 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 wholesale authorisation holder is able to provide the marketing authorisation holder with details of MKT that the product has been subjected to whilst in his care as well as the times and extent of the temperature deviation, this may assist the marketing authorisation holder in formulating his advice to the wholesale authorisation holder."

Source: MHRA GDP Webpage

(中文：https://www.ouryao.com/forum.php?mod=viewthread&tid=235211）

beiwei5du

同求解答，MKT如何应用呢？？我有看到一篇关于MKT很好的文章The Use of Mean Kinetic Temperature (MKT) in the Handling, Storage, and Distribution of Temperature Sensitive Pharmaceuticals（只有英文的，中文方面好像没有讲这方面的），就是自己理解不太清楚，希望蒲友能够搞懂后指教一下。@愚公想改行

呼呼_802

在质量控制实验室和物料指南上有，另MKT计算的方法你可以说一下吗

Doitasyoulike

USP1160上有介绍MKT的用法
总体上来说，MKT是用在温度超标的情况下，评估超标温度对产品的影响。需要注意的是，及时MKT计算出来的值在可接受的温度范围内，但是超标极限温度，例如最高温度也需要考虑。USP上有相应的介绍

1607639226

beiwei5du 发表于 2016-6-7 09:04
同求解答，MKT如何应用呢？？我有看到一篇关于MKT很好的文章The Use of Mean Kinetic Temperature (MKT) in ...

好难 不怎么看得懂 但是大概意思了解