Current Good Manufacturing Practice Design Trends in Active Pharmaceutical Ingredients Facilities

  • Louis A. Angelucci


Since the early 1990s, the Food and Drug Administration (FDA) has focused attention on Good Manufacturing Practice (GMP) compliance within the active pharmaceutical ingredients (API) industry. Over the years, as well as recently, this industry has striven to play catch-up and comply. This paper discusses both general and specific API industry trends associated with this increased compliance effort.

Key Words

GMPs Compliance Validation APIs Facility Trends 


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Copyright information

© Drug Information Association, Inc 1999

Authors and Affiliations

  • Louis A. Angelucci
    • 1
  1. 1.Worldwide Validation, Pharmaceuticals and Life SciencesFoster-Wheeler USA CorporationClintonUSA

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