Quality Risk Management & FMEA
Diapharm supports pharmaceutical companies in establishing and implementing streamlined yet effective Quality Risk Management Systems (QRMS) in accordance with the EU-GMP guideline and ICH Q9. One central tool is the Failure Mode and Effects Analysis (FMEA), an internationally recognized method for the systematic identification and assessment of risks across all areas of pharmaceutical manufacturing.
FMEA in the Pharmaceutical QRMS Environment
A QRMS encompasses much more than just FMEA—however, FMEA remains an indispensable component of a structured pharmaceutical risk management system. The experts at Diapharm assist companies in identifying and prioritizing quality-relevant risks, documenting them in line with regulatory requirements, and implementing them in practice through a lean and transparent FMEA process. This includes both prospective application for planned processes and retrospective analysis of existing workflows.
Proactively preventing errors through FMEA plays a crucial role in reducing deviations and unplanned production interruptions. This not only meets regulatory requirements for systematic risk management but also ensures product quality and sustainably enhances efficiency in the GMP environment.
