Pharmaceutical, Raw Material Identification

How Technology Is Improving Quality Control Processes

Quality Control

Good Manufacturing Practice, or GMP for short, is a legal requirement for the pharmaceutical industry. It exists to ensure that drugs, vaccines and other pharmaceuticals are safe for use and are being produced to a high quality. This is extremely important when considering some of the high profile cases of drugs causing more harm than good, such as the Thalidomide tragedy in the 1960s. As the pharmaceutical industry is constantly researching and developing new remedies and cures, the GMP regulations help to safeguard against future similar incidents. Although GMP regulations can sometimes cause headaches for pharmaceutical companies, their application has been made easier thanks to advances in technology. One area where technology has been improving quality control processes is in temperature monitoring. 

Quality  through temperature monitoring

A key part of quality control is temperature management. WiFi enabled temperature data loggers can allow remote monitoring of multiple sites at once, and can be configured so that you can logon via your mobile device and receive alerts when temperature parameters are compromised. Testo has a range of such devices, which are available on our website. A public health report from 2018 highlighted that continuous electronic temperature monitoring has often proven to be more effective than stem thermometers (Cavallaro et al., 2018). 

 

Data Logger for Quality Control purposes

Testo Saveris 2-H2 WiFi Data Logger

Quality Control through Raman analysis

Another key advance in technology has been in the area of Raman analysis. Raman analysis uses a method of ‘light scattering’ which causes chemical molecules to vibrate at a certain frequency. Such a method is used to correctly identify chemical structure and bonds and is important when it comes to raw material identification – a vital part of any quality control process. Although Raman analysis has been in practice for many decades, the advent of handheld Raman spectrometers has meant that users can now receive lab-quality analysis in the palm of their hands. The Progeny handheld raman spectrometer can correctly identify powder, solid, liquids and other substances thanks to its sophisticated 1064nm laser. Handheld spectrometers such as these mean there is no need to risk contamination by opening incoming containers to take a sample. Sampling is easy, flexible and portable. 

Quality Control and data entry

Of course, it is not just in these niche areas where technology is improving the quality analysis process. Having the ability to log details on handheld devices such as laptops and smartphones has proven to be hugely helpful in the supply chain. Recording information using traditional methods such as pads and pens means risking the records accidentally becoming damaged, or data entry mistakes when replicating these records. A data management system which uses cloud based storage allows all these files to be accessible wherever the user has access to the internet. 

To learn more about our WiFi enabled range of data loggers, or the Progeny handheld raman spectrometer, drop us a line on info@antech.ie and a member of our team will be in touch!

Cavallaro, K. F., Francois, J., Jacques, R., Mentor, D., Yalcouye, I., Wilkins, K., … Tohme, R. A. (2018). Demonstration of the Use of Remote Temperature Monitoring Devices in Vaccine Refrigerators in Haiti. Public health reports (Washington, D.C. : 1974), 133(1), 39–44. doi:10.1177/0033354917742119