Advertisement

Current Good Manufacturing Practice Design Trends in Active Pharmaceutical Ingredients Facilities

  • 2 Citations

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.

This is a preview of subscription content, log in to check access.

Access options

Buy single article

Instant unlimited access to the full article PDF.

US$ 39.95

Price includes VAT for USA

Subscribe to journal

Immediate online access to all issues from 2019. Subscription will auto renew annually.

US$ 189

This is the net price. Taxes to be calculated in checkout.

Author information

Correspondence to Louis A. Angelucci III.

Rights and permissions

Reprints and Permissions

About this article

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

Download citation

Key Words

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