Bulk Actives Post Approval Changes (BACPAC): A European Perspective

Abstract

This article highlights the problems encountered by dedicated active pharmaceutical ingredients (API) and intermediates manufacturers in obtaining Food and Drug Administration (FDA) clearance for changes in their operations, especially process changes. Several suggestions for introducing workable API postapproval change procedures within the framework of the developing FDA Bulk Actives Post Approval Changes (BACPAC) Guidance are presented.

This is a preview of subscription content, access via your institution.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Chris Oldenhof PhD.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Oldenhof, C. Bulk Actives Post Approval Changes (BACPAC): A European Perspective. Ther Innov Regul Sci 33, 763–768 (1999). https://doi.org/10.1177/009286159903300315

Download citation

Key Words

  • BACPAC
  • Process change
  • Active pharmaceutical ingredients
  • GMP
  • Manufacturing