The introduction of appropriate temperature and humidity monitoring systems is becoming essential for pharmacies and other entities storing medicinal products. The requirements, stemming from a regulation by the Minister of Health that will be in force from 3 December 2025, are detailed in an ebook and interview by lawyer Anna Molenda. In this article, we will cite some of the most important topics.
When do the obligations under the Ministry of Health Regulation come into force?
The regulation provides for a 36-month compliance period, ending on 3 December 2025*. During this time, all pharmacies, including SPZOZs and military units, must implement systems to ensure that drug storage conditions comply with the regulations. The introduction of monitoring systems aims to minimise the risk of degradation of medicinal products and increase patient safety.
Does the monitoring system have to operate 24/7?
Yes, the monitoring system must operate continuously – 24 hours a day, 7 days a week. Continuity of operation allows irregularities to be detected immediately and appropriate action taken. These systems should be equipped with an alarm function that can inform the relevant persons via in-app notifications or emails when acceptable parameters are exceeded.
What are the requirements for calibration of equipment?
Monitoring equipment must be calibrated regularly and a calibration certificate should be issued by an accredited body. The frequency of calibration, according to the Polish Pharmacopoeia, is usually 12 months, but in some cases, such as intensive use, more frequent calibration may be necessary. The calibration certificate is an important document that confirms the efficiency of the equipment you use in your facility. With it, you can be sure that the measurements of environmental parameters are real and that any minimal differences do not exceed the manufacturer’s suggested standard.
The documentation of the temperature and humidity monitoring system should include:
- the date and time of the measurement,
- the place where the measurement was taken,
- temperature and humidity parameters,
- signature of the person responsible for the readings.
Data must be retained for a minimum of five years, adequately secured and easily accessible for audits or inspections.
Who is responsible for monitoring in a pharmacy?
The monitoring is the responsibility of the pharmacy manager, who is obliged to supervise the correct functioning of the system and compliance with regulations. He/she may delegate tasks related to the daily operation of the monitoring system to his/her pharmacists or pharmacy technicians. However, the ultimate responsibility for ensuring appropriate storage and transport conditions for medicinal products rests with the pharmacy manager. It is worth mentioning that the proper management of the system, including the analysis of records and the reaction to parameter exceedances, is key to avoiding sanctions during inspections and ensuring the safety of stored products.
If you are unsure how to interpret the regulations, it is worth talking to a lawyer. Such a consultation will help to clarify the requirements for your pharmacy or medical facility and avoid problems during an inspection. It’s a simple way to have peace of mind and be sure that everything you do is legal.
Don’t leave anything to chance – make sure you have the right tools and support!
Find out more details:
- Visit the CoolSens YouTube channel for practical knowledge with tips on temperature and humidity monitoring systems.
