The Ultimate Guide to GLP Compliant Temperature Monitoring
Good laboratory practice (GLP) outlines standards to guide temperature monitoring in the laboratory. GLP compliance is critical because temperature contributes to safety, accuracy, and precision in the lab.
In recent years, temperature monitoring in the laboratory has become a big concern. This is because temperature plays a critical role in laboratory procedures.
Other environmental factors such as relative humidity and differential pressure can also significantly influence the accuracy and precision in facility or procedure. However, the temperature is the underlying factor that is usually of utmost importance.
As a result, the need for accurate lab temperature monitoring is so critical that it is featured prominently in GLP compliance documentation. ELPRO temperature monitoring systems help ensure GLP compliance. They are engineered and certified to be 100% NIST traceable to prove process safety, as well as data integrity. This validation helps contribute to end-consumer safety in the manufacture of pharmaceuticals and drug therapies.
GLP compliance in laboratory temperature monitoring is vital in preventing contamination. Biological and chemical contamination can render cultures unusable or introduce skewed experimental results. It can also help prevent contamination from one specimen to another.
Moreover, in labs that produce pharmaceutical products, adverse temperatures can negatively affect product integrity. Low product integrity manifests itself in shortened shelf life or below standard efficacy.
Apart from these factors, temperature also influences the accuracy of pharmaceutical procedures and lab equipment precision. All these factors highlight the importance of GLP-compliant temperature monitoring in laboratories.
GLP regulations provide a foundation for establishing an effective monitoring system that meets regulatory requirements.
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The Mandate and Scope of GLP
GLP outlines principles for quality assurance in clinical and non-clinical studies to support research and the issuance of government permits to produce pharmaceutical products. The document is an important guidance in the pharmaceutical industry but also includes food additives, food coloring agents, and medical devices.
GLP does not outline scientific standards for use in the lab. Its mandate is to define quality assured standards for conducting studies, data collection, and results reporting.
A key component of GLP compliance is a separate quality assurance unit, whose mandate is to supervise GLP implementation. The unit provides unbiased reporting on implementation that is critical in building confidence in the process and results.
Laboratory Temperature Monitoring Solutions
In the past, manually recording temperature data was the norm in laboratories. Even today, some guidance allows it. However, more and more laboratories today rely on electronic temperature measurement, alarming and archiving. Manual data management is a time-consuming task and ties up valuable time where staff could be focusing on higher priorities. Additionally, the manual recording process is also susceptible to human error and bias. It is also non-traceable.
All these risks made it challenging to attain and prove GLP compliance. The technology has evolved to include 24/7 real-time automated temperature monitoring solutions, such as those from ELPRO, to help overcome the challenges experienced with manual systems.
It is extremely challenging to perform data analysis from physical charts and spreadsheets. Advanced monitoring systems can generate automated reports that users can quickly assess. Automated reporting makes GLP compliance easy and straightforward, and the reports also provide traceable evidence of compliance during audits.
Basic monitoring systems record temperature readings in predetermined intervals and can accommodate alarm settings if high and low temperature ranges are exceeded.
Wired and wireless data loggers and integrated database software solutions, such as those engineered by ELPRO, provide continuous monitoring where sensors record temperature data 24/7/365. Users can assess this data and run reports to ensure quality control and compliance with GLPs. Temperature data logging also provides visibility to alarm history and stability budgets.
Some companies find better economies of scale and greater efficiency in temperature monitoring solutions for GLP compliance in a cloud database. Data uploads to the cloud can provide real-time supply chain visibility, enabling users to remotely monitor critical assets, their condition and their location anywhere on the globe.
ELPRO cloud monitoring solutions provide 24/7 real-time remote access to alarms in addition to unlimited storage capability for all the temperature and other environmental data.
Cloud database solutions also enable automated reporting, and quick analyses.
Macro vs. Mini Environment
A key consideration for GLP compliance in temperature monitoring is the macro and microenvironment. Temperature mapping, sensor selection, and placement will vary both of these environments.
The macro-environment includes the entire laboratory and the room temperature. Temperature mapping for any lab must take into account pockets of cold and hot spots in the facility. Once these spots have been identified, corrective temperature control actions or solutions can help maintain a uniform temperature throughout the entire laboratory.
Hot and cold spots are ideal sensor installation locations for a highly responsive and efficient temperature monitoring system. Apart from temperature control, one may look into structural modifications that can help make temperature monitoring more manageable. A few options may include structural insulation, weatherproofing, and floor plan rearrangement to help ensure uniform heat distribution.
In contrast, the microenvironment includes smaller control areas that include equipment such as freezers, incubators, and coolers. GLP requirements and a company's Standard Operating Procedures (SOP) often dictate different temperature ranges for these microenvironments.
Once temperature range limits for products in the microenvironment are established, systems capable of maintaining those ranges and continuously monitoring them are essential. ELPRO temperature mapping solutions are suitable for macro and micro environments within the lab.
Equipment Qualification Guidance
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Validation and qualification are vital in temperature monitoring in the lab.
Comparing Temperature Sensors
GLP compliance in lab temperature monitoring includes the selection and placement of temperature sensors. Three main types of sensor modalities can fit in lab temperature control.
Analog temperature sensors are easy to use and economical. These sensors compensate for the lack of precise accuracy by having a wide temperature range.
Modern digital thermometers overcome these challenges to offer better capabilities for recording and reproducing results. Resistance thermometers have probes with materials whose characteristics vary with temperature variations. Other sensors in use are thermocouples and infrared (IR) sensors. IR sensors have the advantage of measuring without the need for contact with the sample and provide a wide coverage area. When considering sensors for lab temperature monitoring, the thermometer range and accuracy are things you cannot overlook.
Even with the right kind of sensors, it is necessary to put in place measures to ensure consistency and accuracy. After some time, accurate thermometers will lose their accuracy due to wear and tear and the influence of environmental factors.
GLP compliance requires properly laid down calibration protocols that indicate the procedure and frequency for calibration. Through calibration, you can confirm the performance of a device in terms of accuracy and precision.
Accuracy delineates how far the result is from the expected, while precision measures how consistent the device is in giving the same result under the same conditions.
Additionally, validation and qualification are vital in temperature monitoring in the lab. All these quality management protocols will help to ensure the lab maintains the required environment quality.
Without GLP compliance, lab temperature monitoring will not achieve the purpose of ensuring product safety and consumer protection. A reliable and validated temperature monitoring process for the lab will help make compliance with regulations easy.