Principles for Effective Regulatory Active Pharmaceutical Ingredients Policy
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Principles for Effective Regulatory Active Pharmaceutical Ingredients Policy Arthur C. Fabian Drug Information Journal 1999 33: 747 DOI: 10.1177/009286159903300313 The online version of this article can be found at: http://dij.sagepub.com/content/33/3/747
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Drug Information Journal, Vol. 33, pp. 147-153. 1999
00!92-8615/9!3
Copyright Q 1999 Drug Information Association Inc.
R i n d in the USA. All rights reserved.
PRINCIPLES FOR EFFECTIVE REGULATORY ACTIVE PHARMACEUTICAL INGREDIENTS POLICY ARTHUR C.FABIAN,PHD Executive Director, Technical Affairs, SST Corporation, Clifton. New Jersey
This article develops the premise that there are a fewfundamental principles that underlie the effective regulatory active pharmaceutical ingredients (API)policy/practices of individual companies, as well as of the Food and Drug Administration (FDA) itself. These principles become evident when one evaluates, retrospectively, ineffective API policy/ practices and critically examines the basic reason(s)for their ineffectiveness. The principles are: Science-based decisions; APIs are not dosageforms; continuity; andproportionality. In addition to discussing each principle, they are also presented in the context of specific API issues, including process changes, investigational new drughew drug application (INDDVDA)documentation, current Good Manufacturing Practices (cGMPs) and process validation. Practical recommendations are offered concerning the “how” of applying these principles. Key Words: GMP; Policy; Validation; API; Principles
INTRODUCTION THOSE OF US WHO have been in the API industry for more than a decade, are in a unique position to think about the existence of both very effective and very ineffective API policies. It leads one to wonder if there are common characteristics of the effective regulatory policies which are minimized or completely absent in the ineffective policies? I would like to develop the premise that indeed there are such characteristics or principles for effective regulatory API policy and postulate what they might be. This is done Presented at the DIA Fourth Symposium on Active Pharmaceutical Ingredients: “Issues at the Development, Production, Regulatory Interface,” November 8-11, 1998. Reprint address: Arthur C. Fabian, PhD,Executive Director, Technical Affairs. SST Corporation, 635 Brighton Road, Clifton, New Jersey 07012.
to provide a tool with which one can evaluate policy emerging from both the FDA as well as one’s own company, thereby minimizing ineffective API regulatory policy. T
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