GMP Pharmacy Guide for Temperature Monitoring
There are various methods to comply with GMP standards in the pharmaceutical environment. Read on to learn more about compliant ways of temperature monitoring.
Use of Handwritten Maximum-Minimum Lists
For handwritten temperature logs, personnel are required to manually record the temperature that has been shown on the equipment. Temperature is usually checked daily but can sometimes stretch to two times in one day.
A lab technician is, more often than not, the person who walks around recording the temperature figures on a notebook. Most organizations have standard operating procedures (SOP) that suggest a minimum of four hours duration to be established between the two temperature checks.
However, in a busy lab, it may be challenging to find time to walk around recording the temperature. This poses a risk in the process and makes this an inefficient method of data collection.
Additionally, the data collected is not secure. It can be easily changed in the notebook, and the risk of forgetting to record the temperature due to a tight schedule is also relatively high. On top of this, the data storage also poses a considerable risk as the book can be misplaced.
All these challenges make this a high-risk form of pharmaceutical temperature monitoring and should be understood first before adopting this method.
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Use of Chart Recorders
Chart recorders were arguably the most used temperature monitoring method, more so in pharmacy temperature monitoring. Their widespread use continues to be seen in many organizations, and chances are these paper charts were used in your organization for many years.
However, removing filled data charts and replacing them with new charts, storing these charts, checking temperature graphs, and writing the deviation reports can often lead to human error due to the manually intensive nature of this method.
On top of this, any reports or notations to be made on the charts required the use of the ALCOA principle that was quite tedious. A designated and independent archivist, in a controlled and protected area, is the only person allowed to store all the charts. This, too, brought out a huge downside in the use of this method in the pharmacy temperature monitoring system.
For example, what if an auditor asks for temperature data that was recorded a year ago? Can this information be accessed swiftly and promptly?
These are some of the questions that should be addressed before using this outdated technology that has been used for more than 100 years in pharmaceutical temperature monitoring.
Use Digital Data Loggers
This is a modern and digital method for pharmacy temperature monitoring as opposed to the two previous ways. Here, data loggers collect the temperature data. Most times, they also come complete with a built-in memory.
This information automatically has a timestamp that comes in handy when regulatory bodies ask for this data to ensure compliance. To retrieve this data or generate any report, one would only need to connect the data loggers to a computer.
The huge advantage of using this method as a pharmacy temperature monitoring solution is that the data is collected and later stored in an electronic format that complies with many regulations.
The disadvantage is that you will have to manually manage the loggers. You can connect them to a computer USB or Bluetooth® connection to retrieve the data.
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Use of Independent Monitoring Solutions for Rooms and Equipment
This is an upgrade from digital data loggers and the latest in terms of technology in the digital data logging arena. They are stand-alone components that use self-powered systems and are virtually hands-free by incorporating an easy-to-read base.
The most important information such as temperature, warnings, battery life, and alarms are shown directly on the data loggers, which should be in clear view to the pharmacist.
When the data loggers have reached a temperature excursion, the data logger base activates an alarm. Some independent monitoring systems were designed explicitly for pharmaceutical temperature monitoring that has a pharmacist who prefers to spend time with the customers instead of writing temperatures manually. The base is connected to a computer via a USB connection to retrieve information from the data logger.
Use of Networked Data Loggers
Networked data loggers, referred to as a central monitoring system (CMS), are loggers that automatically collect temperature readings or any other environmental data that it was configured to monitor and then sends the collected data to a computer or network that is part of a centralized system.
This pharmaceutical temperature monitoring method is highly efficient in reducing manual work involved in data retrieval. Automatic information archiving via networked data loggers ensures that data collected is securely stored to meet integrity guidelines and future reference.
Central monitoring systems can save an organization considerable cost, as the time it takes to write down the temperature data readings manually is no longer required.
Some of the networked pharmacy temperature monitoring systems also provide analytical tools for statistics and reporting. The time and date stamps that are also collected with the temperature readings offer an in-depth analysis. In the event of a temperature excursion, this system will send a remote alarm notification so that action can be taken immediately.
Additionally, some pharmaceutical temperature monitoring systems even provide the option of setting up a programmable alert notification that will send a message before a problem has happened.