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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Oldenhof, C. Bulk Actives Post Approval Changes (BACPAC): A European Perspective. Ther Innov Regul Sci 33, 763–768 (1999) doi:10.1177/009286159903300315
- Process change
- Active pharmaceutical ingredients