How have we optimized work and minimized the temperature compliance procedures of the Croatian manufacturer of OSTEOGROW cure for bone regeneration?
The production of medicines is regulated by GMP guidelines, which, among other things, require the use of qualified equipment for temperature and environmental control. Here, special emphasis is placed on the procedure of monitoring and recording the temperature, which must be traceable, continuous and accompanied by written records of temperature deviations. In order to meet the stringent temperature requirements of regulatory bodies, the Croatian manufacturer of OSTEOGROW therapy for bone regeneration has replaced existing solutions with our Eupry system for monitoring temperature conditions in cooling devices with sensitive substances for production.
OSTEOGROW - Prospective therapy for bone regeneration
OSTEOGROW is the first drug of the Croatian manufacturer Genera istraživanja d.o.o. which was brought to phase II clinical development. The production of this innovative drug for bone regeneration is located in Kalinovica near Sveta Nedjelja, where the production plant is located, which produces bone-morphogenic protein BMP6 - the active substance of OSTEOGROW, which is being tested in clinical studies in orthopedic surgery.
The drug has been recognized by orthopedists and traumatologists throughout Croatia and beyond as a valuable therapy that will significantly improve the quality and speed up the healing of bone fractures, but also shorten the treatment of patients with bone tumors.
Temperature challenges of GMP production
The production of OSTEOGROW is regulated by the Good Manufacturing Practice (GMP) guidelines, which ensure that all products are equally manufactured and controlled to a quality standard that is suitable for their application according to applicable regulations. According to these guidelines, the importance of using qualified equipment and procedures to check the environment in which medicines are produced and stored is crucial, taking into account the monitoring of environmental conditions such as temperature and humidity.
Previous methods of temperature monitoring in the premises of Genera istraživanja d.o.o. involved the use of digital thermometers, which are not completely reliable and require physical temperature readings and recording in temperature lists. A special disadvantage of this method is the physical reading of the results, which consumes the valuable time of laboratory staff, as well as the inability to monitor the temperature in real-time.
In our area, the main challenge every day is to monitor the temperature conditions in the chambers outside the working hours of the laboratory. The temperature is visually read by laboratory staff and the readings are
manually entered into the temperature list, which is a very time-consuming process.
Dora Adanić, Chief Operating Officer, Genera Research Ltd
In order to make it easier for the manufacturer to monitor the temperature in refrigeration units that store valuable substances for the production of OSTEOGROW medicine, we introduced them to the new Eupry system, which proved to be a worthy replacement for existing solutions.
Eupry system - An innovative solution for temperature control
The process of temperature monitoring using the Eupry solution, for Genera Research, has proven to be effective for the following reasons:
- Carefree work of laboratory staff and recording of temperature data
The implementation of the Eupry system has enabled continuous temperature measurement in incubators, freezers and refrigerators, via the existing Wi-Fi network. Automatic recording of temperature data in the online application, has significantly saved time for laboratory staff who no longer have to manually read the results, but can be focused on daily work tasks. The need for physical handling, as well as the possibility of human error in physically recording the results, are completely minimized.
- Real-time monitoring of temperature conditions
In case of physical absence of laboratory staff or accidental failures such as left refrigerator door open, sudden breakdowns or power outages, the system automatically sends alarms to staff in the form of free SMS and e-mail alerts, allowing them to monitor conditions in real time and respond in a timely manner in case of temperature deviations.
- Minimized procedures for temperature data compliance
The Eupry system allowed the manufacturer to generate temperature reports and quickly export data in accordance with regulatory requirements and 21 CFR, part 11 of the guidelines, thus completely shortening the process of preparation for regulatory controls and temperature compliance procedures.
Successful cooperation
If you want to find out more about the implementation of the Eupry data logger for temperature monitoring in the pharmaceutical industry, read the details in the document in which we described the successful collaboration with Genera Research.
