Application of Failure Modes and Effects Analysis (FMEA) for Conducting Multiple Risk Assessments in a New Pharmaceutical Facility
Abstract
Global pharmaceutical compliance frameworks, WHO GMP, and ICH Q9 (R1) all require the application of Quality Risk Management (QRM). Infrastructure, clean utilities, sterilization systems, environmental controls, and process equipment are all intricately integrated in recently built pharmaceutical production plants, generating a number of possible sites of failure during commissioning. Therefore, to guarantee operational robustness and regulatory compliance, a proactive and organized risk assessment strategy is crucial.
For the risk-based commissioning of a new oral solid dosage production facility, this study suggests an integrated, multi-domain application of FMEA. A group of people from different departments worked together to use FMEA in five important areas: the steps for introducing new products, the equipment used for sterilizing, the system for making pure steam, the system for making purified water, and the design and layout of the facility. ICH Q9-aligned Severity, Occurrence, and Detection score was used to identify and rank the risks. The design concept for facility lifecycle management included structured mitigation techniques.
The suggested integrated FMEA model supports ongoing GMP adherence and improved quality assurance during pharmaceutical facility implementation by providing a scalable and regulatory-aligned method for early risk identification, cross-functional cooperation, and proactive compliance management.
Conclusion: This paper demonstrates that the combination of an inter-domain application of the FMEA provides a structured and efficient approach to risk identification and reduction during commissioning of pharmaceutical facilities. It ensures enhanced operational reliability, cross-functional teamwork and continuous compliance with GMPs, by complying with ICH Q9. Altogether, it can be concluded that the model offers a versatile model of the proactive quality risk management in modern pharmaceutical manufacturing.
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https://link.springer.com/article/10.1007/s00170-020-06425-0
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