WHO PQS Process
WHO Performance, Quality and Safety (short PQS) process prequalifies products, equipment and devices so that UN agencies and member states are assured of their suitability for use in immunization programs. This process also encourages manufacturers to apply for prequalification resulting in a competitive marketplace. Any device, equipment or product that has complied with WHO rules and regulations is said to be WHO prequalified.
WHO PQS EOO6 are temperature monitoring devices. WHO prequalified temperature monitoring devices are thermometers, temperature recorders, freeze indicators, alarm systems, event loggers and remote communication devices. Also, any monitoring temperature device at all levels of the cold chain and is WHO prequalified belongs to this category.
The WHO PQS team has created a three-step innovation, product development and improvement cycle that aims to bring all the key players into a productive relationship. It includes:
Adoption of international standards as a basis for the design, development and production of each product type.
Developing and maintaining technical specifications for each product type. This relates to testing procedures that reflect on programmatic and operational needs.
Monitoring of each product in the market thus assessing its performance, quality and safety characteristics throughout its life cycle.
WHO prequalified devices have proved to be massively beneficial in ensuring vaccine quality within the cold chain.
Thanks to WHO prequalified devices and equipment, recording temperature is easier. These devices digitally record temperature making the process cheaper when compared to manually recording temperatures. Labor costs can be overwhelming considering vaccines require the temperature to be taken daily and within a specified time. In case of any potential problem you will immediately be notified, thus preventing wastage.
Temperature monitoring devices do not cost as much as you think. They offer a low-cost and reliable solution to record and monitor the temperature of vaccines and medicines.
Temperature monitoring devices record temperatures at configurable intervals thus ensuring medications and vaccines are stored at the appropriate temperature. This also ensures that the equipment is working properly. Such features are very beneficial in maintaining regulatory compliance as required by WHO. All reports are automatically put together and sent to you via text or email depending on how you choose.
Compared to the Vaccine Vial Monitor (VVM), these devices have a scientific accuracy that aids in the accuracy that they give, since temperature can be monitored from the outside without disturbing the inner environment. Not only do they provide a versatile way of collecting data, but they also provide the means to better monitor and analyze temperature data in real-time. Manual reports provide room for inaccuracy and upkeep is a hassle. Unlike using the new technology of WHO prequalified devices, there is no need to worry about the accuracy and the validity of the overall records. The recording process of these devices is much simpler, easier and has higher accuracy, therefore, the results are perfect.
Unlike manual recording that requires a person to be near the temperature system, WHO prequalified equipment and devices can be accessed from anywhere at any time. Reports can be sent to you directly through SMS, email or an APP that has been integrated with your system. This eliminates the need to check individual loggers. Accessibility has proven to be very beneficial in using temperature monitoring devices.
The installation and maintenance processes of manual systems can be much longer and inconvenient. Also, they tend to lack user-friendliness. On the other hand, temperature monitoring devices are easy to set up and use. Their size comes in handy in that they are not bulky and heavy. Thus, they cannot interfere with the temperature measurements.
Temperature monitoring devices have intelligent warnings notification when the normal parameters are breached. Thus, clients have more freedom from manual monitoring and have higher reliability and accuracy. By giving clients higher response times they can prevent further damage to the vaccines and medications while they are in transit. The data can then be viewed in audit-ready reports.
Enabling clients to access data from wherever they are on their internet-enabled devices allows them to save time. The fact that data is recorded and analyzed at the same time leaves no room for mistakes and errors.
Data loggers can be classified according to what it is they are measuring. This may be temperature, humidity or even pressure. The four main types of data loggers are:
USB data loggers: Reusable, portable, compact, easy to set up and low cost. They have internal sensor models that are used for monitoring at the logger location, whereas the external sensor models are used to monitor while distant from the loggers. These data loggers communicate with a computer through a USB interface.
Wireless sensors: Data loggers that transfer real-time data from dozens of points to a single gateway or computer. Thus, they eliminate the need to offload and retrieve data manually from each data logger.
Bluetooth-enabled loggers: Reusable, compact, easy to use/set up and portable. These WHO prequalified devices can measure and transmit data wirelessly to other devices. They come in handy mostly in hard-to-reach areas. You can access the logger via your smartphone without having to disturb it.
Web-based data logging systems: Enable an all around-the-clock, remote and internet-based data access through the public cellular network. They allow the transmission of collected data to a secured web server that can be used to access the data.
These take measurements every minute and they compare them with a pre-programmed defined stability budget. They reflect the freeze or heat sensitivity of the shipped vaccine and they have alarm limits and allowed excursion times.
These data loggers are used to measure and store temperature that can be used to further download and analyze the measurements in a cloud database or PC. They are commonly used in monitoring bulk shipments or for temperature mapping purposes.
These loggers are placed with the vaccine load in the vaccine refrigerator. Depending on your given interval, they log the refrigerator temperature for 30 consecutive days. The measurements are given on a rolling basis and the alarms are sent either through SMS or email.
These data loggers are perfect for ultra-low or frozen shipments on dry ice or in cryogenic containers. There is a wide range from which you can choose, from internal to external probe options to single-use or multi-use. The named data loggers feature multi-level programming with a well-established eight-level alarm system and PDF reporting.
For safe and effective immunization delivery, WHO prequalifies a comprehensive range of cold chain equipment that ensures vaccine quality throughout the supply chain. ELPRO is a global leader in environmental data monitoring solutions and GxP services with over 30 years of experience. Here at ELPRO, not only do we take care of efficiency and compliance throughout the whole process, but also we help make medicines safe for patients. Simple and inexpensive solutions are needed to take into account the difficult situation in the receiving countries. However, temperature monitoring devices are key and ELPRO products have combined the latest technology in ensuring that vaccine quality is not compromised at any cost.