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A Brief Review Of Fda’S Novel Tools For Ensuring Pharmaceutical Quality In The Human Drug Supply Chain, Heather R. Campbell, Robert A. Lodder
A Brief Review Of Fda’S Novel Tools For Ensuring Pharmaceutical Quality In The Human Drug Supply Chain, Heather R. Campbell, Robert A. Lodder
Pharmaceutical Sciences Faculty Publications
Purpose
Pharmaceutical manufacturers execute quality control operations and Good Manufacturing Practices (GMP) to provide safe drugs. The Federal Drug and Food Administration (FDA) is tasked with ensuring manufacturers are performing such procedures. Faced with limited resources the FDA has developed novel tools to aid pharmaceutical manufacturing oversight. This paper briefly reviews these tools.
Methods
Current inspection approaches employed by the FDA are identified by searching the FDA’s guidances, the Code of Federal Regulations, public reports and other online resources.
Outcomes
Industry
A risk-based site selection model (SSM) is used to prioritize on-site inspections for FDA investigators. Theoretically, the SSM allows …