Automation & IT / Fluid Handling / Reliability & Maintenance

Instrumentation: Cut Maintenance Costs Via Internal Diagnostics

Simplifying instrument verification can minimize expensive calibrations.

By Ravi Shankar, Endress+Hauser, for our sister publication Pharmaceutical Manufacturing

Recently, Quality Risk Management (QRM) has become a mandatory regulatory requirement for drug manufacturers. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) publish guidelines and requirements which customers and vendors are expected to follow. Guidelines such as “Process Validation: General Principles and Practices” by the FDA and Annex 15 issued by the EMA offer input to help drug manufacturers design processes correctly.

Want to achieve greater insights, better decisions and more intelligent  operations overall. Embrace Industry 4.0!  REGISTER NOW

Based on the new process validation model published by the FDA, validation is never finished, but is instead a process of continuous improvement. Maintenance and calibration activities of instruments are part of stage three in the model.

QRM is an overall and continuous process to minimize product quality risk. Instrument calibration/verification interval definitions are part of QRM risk analysis, and guidelines for these procedures are described by the FDA and EMA accordingly. Selecting the correct instrument for the application is absolutely crucial in the design phase of the project, and the criticality of the measuring point defines the required reliability and measuring accuracy of the instrument.

Read the rest of this article from our sister publication Pharmaceutical Manufacturing.

 

Free Subscriptions

Chemical Processing Digital Edition

Access the entire print issue on-line and be notified each month via e-mail when your new issue is ready for you. Subscribe Today.

chemicalprocessing.com E-Newsletters

Stay ahead of the curve with free e-newsletters and alerts. They are delivered to your inbox on a regular basis and you may unsubscribe at any time. Subscribe Today.