viernes, 12 de julio de 2019

Ensuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators

The Mutual Recognition Agreement (MRA) with the European Union (EU), allows FDA to more effectively deploy our inspectional resources across the globe.

As drug manufacturing has globalized, ensuring that companies meet the U.S. Food and Drug Administration’s (FDA) strict standards for producing safe, effective and high-quality medicines has become increasingly challenging. One way the FDA has addressed this challenge is through the Mutual Recognition Agreement (MRA) with the European Union (EU), which allows us to more effectively deploy our inspectional resources across the globe.

Pharmaceutical establishments that make active pharmaceutical ingredients and finished drug products used by U.S. patients are subject to routine inspections by the FDA to determine if they are in compliance with Current Good Manufacturing Practices (CGMP). The FDA prioritizes and schedules these inspections, which we call surveillance inspections, based on a risk-based site selection model. During an inspection, FDA investigators focus on whether the facility is adequately controlling its manufacturing operations. This includes establishing strong quality managements systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations and maintaining reliable testing laboratories. With 4,600-plus registered establishments subject to surveillance inspections, three-fifths on foreign soil, routine surveillance is a large-scale endeavor for the FDA.