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.
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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.