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

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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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Authors and Affiliations

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

    Chris Oldenhof PhD (Vice Chairman, Manager)

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

    Chris Oldenhof PhD (Vice Chairman, Manager)

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  1. Chris Oldenhof PhD
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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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  • DOI: https://doi.org/10.1177/009286159903300315

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