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

Drug information journal : DIJ / Drug Information Association volume 33, pages763–768(1999)Cite this 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.

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Affiliations

  1. Vice Chairman, Manager, European API Committee of European Chemical Industry Council (CEFIC), Delft, Netherlands

    Chris Oldenhof PhD

  2. Vice Chairman, Manager, International Regulatory Affairs, DSM/Gist-brocades B.V., Business Group, Anti-Infectives, PO Box 1, 2600 MA, Delft, The Netherlands

    Chris Oldenhof PhD

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  1. Chris Oldenhof PhD
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Correspondence to Chris Oldenhof PhD.

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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

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Key Words

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