Current Good Manufacturing Practice Design Trends in Active Pharmaceutical Ingredients Facilities

Drug information journal : DIJ / Drug Information Association volume 33, pages739–746(1999)Cite this article

Abstract

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.

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Affiliations

  1. Director, Worldwide Validation, Pharmaceuticals and Life Sciences, Foster-Wheeler USA Corporation, Perryville Corporate Park, Clinton, New Jersey, 08809-4000, USA

    Louis A. Angelucci III

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  1. Louis A. Angelucci III
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Correspondence to Louis A. Angelucci III.

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Cite this article

Angelucci, L.A. Current Good Manufacturing Practice Design Trends in Active Pharmaceutical Ingredients Facilities. Ther Innov Regul Sci 33, 739–746 (1999). https://doi.org/10.1177/009286159903300312

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Key Words

  • GMPs
  • Compliance
  • Validation
  • APIs
  • Facility
  • Trends