Quality control of pharmaceuticals is extremely important from production to storage and distribution.
In particular, temperature and humidity control are essential to prevent deterioration of pharmaceuticals and maintain their quality.
Recently, wireless temperature/humidity monitoring solutions have been attracting attention.
(記事更新日:2025.01.20)
Table of contents
The Pharmaceuticals and Medical Devices Act (Act on Ensuring Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc.) provides the basis for quality control of pharmaceuticals and medical devices in Japan.
This law prescribes strict standards for the manufacture, sale, and distribution of pharmaceuticals, with particular emphasis on quality control during the manufacturing process.
Specifically, manufacturers must establish appropriate management systems and manufacture in accordance with Good Manufacturing Practice (GMP) to ensure product quality.
Quality control based on the Pharmaceuticals and Medical Devices Act and smart wireless temperature/humidity monitoring solutions are interrelated.
It stipulates the control standards necessary to ensure the quality of pharmaceuticals, and by following these standards, manufacturers are required to guarantee the safety and efficacy of their products.
Meanwhile, temperature/humidity monitoring solutions provide a concrete means to meet these standards.
This makes it possible to grasp fluctuations in temperature and humidity during the manufacturing process and in the storage environment in real time and respond quickly if necessary.
In this way, it is expected that quality control based on the Pharmaceuticals and Medical Devices Act can be carried out more effectively by utilizing smart wireless temperature/humidity monitoring solutions.
The smart wireless temperature/humidity monitoring solution is a technology for real-time monitoring of temperature and humidity in pharmaceutical manufacturing and storage.
This system is essential to maintaining the quality of pharmaceutical products, especially as fluctuations in temperature and humidity can affect product degradation and efficacy.
If temperature is not properly controlled, pharmaceutical constituent may decompose or become less effective.
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Meet the latest regulatory requirements to ensure the quality and safety of pharmaceutical products. (Photo shows MD8000 Series)
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