The pharmaceutical industry plays a great role in the health care system, ensuring the high quality and safety of medicinal products. The Ministry of Health is introducing a regulation that requires the monitoring of temperature and humidity in pharmaceutical storage areas. According to the regulations, the environmental conditions in pharmaceutical storage areas must ensure the preservation of the pharmacological properties of the products and the safety of patients. Deviations from the recommended conditions can lead to the degradation of active substances, reducing efficacy or making medicines unsafe.
Storage requirements for medicines
The regulations require temperature to be monitored continuously in every room and refrigeration unit used to store medicines. Temperature must be recorded at an appropriate frequency and alarms triggered when standards are exceeded. Humidity should be monitored in sensitive storage areas to prevent loss of product properties. The results of temperature and humidity measurements should be archived for at least five years, ensuring their availability during inspections. Alarm systems allow a rapid response in the event of cooling failures or deviations from established environmental standards.
Relevance to the pharmaceutical industry
Mandatory monitoring of environmental conditions increases patient safety and minimises financial losses due to damage to pharmaceutical products. Non-compliance can lead to financial penalties, drug recalls and loss of patient confidence. Advanced monitoring systems optimise storage and logistics, reducing operational costs for pharmaceutical companies. Monitoring conditions in the production, storage and distribution areas is a key element of quality management in the pharmaceutical industry.
Technologies supporting monitoring
Modern IoT solutions make it possible to automatically and remotely control the storage conditions of medicines in real time. Temperature and humidity sensors send data to central management systems, ensuring accurate monitoring of fridge and room conditions. Data analysis systems create reports and alert on deviations, facilitating the management of pharmaceutical storage. Remote management allows you to control the storage conditions of pharmaceuticals, increasing the safety of logistics, especially during transport.
The regulation of the Minister of Health* raises management standards in the pharmaceutical industry, protecting medicines from the negative impact of inadequate storage conditions. Modern monitoring technologies allow pharmaceutical companies to effectively manage storage processes, increasing the safety and quality of the products on offer.
*in Poland
