Quality Risk Management in the Pharmaceutical Air Compressed Equipment Qualification Process
Meléndez Alvarado, Juliemar
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In the pharmaceutical industry every product and every process associated with risks. To maintain product quality throughout the product life cycle, too much time and resources are allocated. Risk is described in recent project as a combination of the probability of occurrence of harm and the severity of that harm. The Quality Risk Management (QRM) approach initiated by regulatory agencies with recognized management tools along with support of statistical tools in combination allows for a risk-based approach to quality management, thus ensuring that resources are deployed in a timely and expeditious manner to areas that need them most. QRM improves risk awareness and accelerates detection of potential issues by analyzing and comparing existing data from a quality perspective to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System. This project describes practical ways to analyze the risks to compressed air quality system, providing guidance along the way to achieving effective and efficient quality management and compliance through QRM. Key Terms - GMP, ISO 8573-1:2010 class two (2), Quality Risk Management, Risk assessment.