AstraZeneca is one of the world’s leading biopharmaceutical companies with 30 manufacturing sites in 20 countries. The company has over 62,000 employees worldwide and sales in 2009 totalled $32.8 billion. Their products are available in more than 100 countries.
The pharmaceutical industry is strictly controlled by institutions and regulations, such as the Food and Drug Administration’s (FDA) Good Manufacturing Practice requirements (GMP). Calibration is one of the fields fenced by very strict regulations. The GMP requirement 21 CFR Part 11, which regulates how the calibration certificate is documented and signed electronically, is essential to the working process.
All equipment and instruments in the production process must be calibrated regularly to ensure they function as they should and, for example, give the correct dosing of all the various substances. This involves testing if a sensor gives the correct measurement result in various conditions, such as temperature, atmospheric pressure, air humidity, and so on. It’s vital that the instrument stays within the acceptable tolerances and that their readouts give correct measurement values, otherwise the final products may be faulty. Calibrating the instruments and devices is of great importance to avoid this type of risk altogether.
Previously, calibration was primarily done with manual and paper-based processes. The certificate was on paper, which was signed and stored in binders. After implementing the new calibration management process, the entire process takes place digitally, from measurement to signing and archiving.
Tomas Wahlgren, System Owner (GOI), AstraZeneca, Sweden
The solution and main benefits
AstraZeneca Sweden Operations ended up procuring Beamex’s CMX calibration management software (CMX for server) with the Pocket PC option and documenting Beamex MC5 Multifunction Calibrators. The use of CMX with the Pocket PC option allowed AstraZeneca Sweden Operations to extensively utilize PDAs (Personal Digital Assistant) for manual data entry on site. The server version of CMX made it possible for several plants within the corporation to use and share the same database.
Being compliant to regulatory requirements, CMX was also very essential to AstraZeneca. With CMX, AstraZeneca Sweden Operations has a validated calibration system with full Audit Trail compliant with 21 CFR Part 11. “According to suppliers of maintenance systems, we have introduced the most effective, automated and validated calibration process known in the pharmaceutical industry. Furthermore, purchasing the Beamex calibration management system has added functionality to our business as we are now able to calibrate weighing instruments as well”, Anders Rackow states.
The total investment for the new uniform calibration process and all the mobility supporting it amounted to $600,000. The calibration process proved to be very cost-effective. The pay-off time was one year. “The greatest profit was made during 2005 and 2007 when the work process was made more efficient through automation and increased mobility with calibrator MC5 and the CMX support system. The calibration management process became simple and completely electronic, which resulted in a decreased number of performers. The implementation of this uniform system has created a “best practice” for the entire AstraZeneca”, Anders and Tomas say.
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