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Temperature Monitoring of Pharmaceuticals

Simply stated, the temperature and environmental conditions affects everything. Unacceptable levels of change can breakdown or change a material through chemical reactions, biological growth and interference, or desiccation.

01 Industries Dependent on Temperature Control

Temperature and/or environmental monitoring becomes a necessity when ensuring something is performing at its prime or intended purpose. With the pharmaceutical and food consumer products industries being among the largest and arguably the most important, it is of no surprise environmental and temperature monitoring is paramount in production and distribution of food and drugs.

 

What threats come from temperature change?

What is it? In the absence of temperature monitoring, a plethora of changes occur, which are not always visible to the eye.

02 Temperature Monitoring Regulations for Pharmaceuticals

You may have a great idea. You may even have the cure. But, before you get too excited, you are going to have to prove to the authorities that you are distributing a product that is safe. The proof is a regulated paper trail of every detail involved in production and distribution. We’re talking about details regarding the housing facility, equipment, personnel, packaging, shipping, data and research, and environmental conditions.

 

The idea is to show that every element of the project is performed as intended. There should be evidence that data is secure and accurate, there has been no security breach, and no one has tampered with the product. Additionally, there should be evidence that the product was kept within conditions that are favorable to the product’s efficacy and safety. This is the only way to realistically anticipate the impact the product will have on the consumer.

Temperature Monitoring Regulations

What are the regulations, and who are the authorities?

03 Monitoring Systems that Work

If your goal is to monitor the environment in which your product is exposed, your monitoring equipment must be accurate. To be compliant with regulatory standards and to ensure quality, you must show proof of sensor calibration. Calibration demonstrates that a sensor is accurate by comparing its output to a verified standard. Calibration verifies the precision and reproducibility of the sensor’s measurements.

 

Calibration justifies qualification. The calibration certificate is the documented proof that the monitoring sensors work correctly to achieve the expected results. Qualification is the initial step of validation, the first step in demonstrating that a process’s results are expected and consistent.

 

The next step of validation is thermal mapping. Loggers are placed strategically throughout a room or container in order to identify the most hot and cold areas. Either the areas are altered to fix the temperature extremes, products are moved from the areas, or sensors are permanently positioned in the areas.

The Pharmaceutical Temperature Monitoring Process

The big three: Calibration, Qualification, and Validation

04 The Audit Trail

“If you didn’t document it, it didn’t happen.”

 

I think you may have heard that one before. In the eyes of an auditor or governing authority, that quote very well may be true. That being said, it would be wise to annotate too much rather than too little. An audit trail is the collection of documents that detail every part of your project, from start to finish. You probably may have already identified documents that should be saved and updated regularly. For example, the user requirement specifications (URS), standard operation procedures (SOP), certificates, training programs, contractual agreements, raw data, etc. The list goes on. . . But when discussing the requirements of temperature monitoring alone, there are specific elements to annotate.

What is in the audit trail?

Find out the "who, what, where, when, and why" of temperature reporting.

In focus

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