Bulk Actives Post Approval Changes (BACPAC): A European Perspective
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Bulk Actives Post Approval Changes (BACPAC): A European Perspective Chris Oldenhof Drug Information Journal 1999 33: 763 DOI: 10.1177/009286159903300315 The online version of this article can be found at: http://dij.sagepub.com/content/33/3/763
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0092-86 15/99 Copyright 0 1999 Drug Infomiation Association Inc.
Drug I n f o m f i o n Juournal. Vol. 33. pp. 763-1631. 1999 Printed in the USA. All rights rezervcd.
BULK ACTIVES POST APPROVAL CHANGES (BACPAC): A EUROPEAN PERSPECTIVE CHRIS OIBBNHOF,
PHD
Vice Chairman, European API Committee of European Chemical Industry Council (CEFIC), and Manager, International Regulatory Affairs, DSM/Gist-brocades. Delft, Netherlands
This article highlights the problems encountered by dedicated active pharniaceutical ingredients ( A P I ) and intermediates manufacturers in obtaining Food and Drug Administration (FDA) clearance for changes in their operutions. 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 phammceutical ingredients; GMP; Manufacturing
INTRODUCTION “BULK DRUG MANUFACTURING is truly an international industry and has a direct impact on all aspects of pharmaceutical development. It is often necessary for industry to make changes in the manufacturing process for economic, environmental, and a variety of other reasons. Both FDA and industry realize the importance of addressing the impact of these changes from a sound scientific standpoint.” This quote from the introductory remarks in the brochure which announced the “American Association of Pharmaceutical ScientistsFDA Workshop on Drug Substance Manufacturing Changes: Global Perspective,” held March 25-27, ~
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Presented at the DIA Fourth Symposium on Active Pharmaceutical Ingredients, “Issues at the Development, Production, Regulatory Interface,“ November 811, 1998, Baltimore. Maryland. Reprint address: Chris Oldenhof. PhD. Manager, International Regulatory Affairs, DSM/Gist-brocades B.V., Business Group, Anti-lnfectives, PO Box I . 2600 MA Delft, The Netherlands.
1997 in Arlington, Virginia may be regarded as the basic statement underlying the current FDA initiative to develop a new guidance on Bulk Actives Post Approval Changes. This may be summarized as: Change in API manufacture is a continuous necessity and should be fostered by the regulatory system.
DISCUSSION As will be i
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