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

  • Chris Oldenhof
Article

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.

Key Words

BACPAC Process change Active pharmaceutical ingredients GMP Manufacturing 

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Copyright information

© Drug Information Association, Inc 1999

Authors and Affiliations

  • Chris Oldenhof
    • 1
    • 2
  1. 1.European API Committee of European Chemical Industry Council (CEFIC)DelftNetherlands
  2. 2.International Regulatory AffairsDSM/Gist-brocades B.V., Business Group, Anti-InfectivesDelftThe Netherlands

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