The Active Pharmaceutical Ingredients Starting Material (Apism) and other Materials in API Manufacture: Scientifically-B
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The Active Pharmaceutical Ingredients Starting Material (APISM) and Other Materials in API Manufacture: Scientifically-Based Principles for the Common Technical Dossier Helga Möller and Chris Oldenhof Drug Information Journal 1999 33: 755 DOI: 10.1177/009286159903300314 The online version of this article can be found at: http://dij.sagepub.com/content/33/3/755
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Drug Informution Journal. Vol. 3 3 , pp. 755-761, 1999 Printed in the USA. All rights reserved.
Copyrighr 0 1999 Drug Information Association Inc.
THE ACTIVE PHARMACEUTICAL INGREDIENTS STARTING MATERIAL (APISM) AND OTHER MATERIALS IN API MANUFACTURE: SCIENTIFICALLY-BASED PRINCIPLES FOR THE COMMON TECHNICAL DOSSIER HELGAMOLLER,PHD *
I
Vice President, Central Laboratory of German Pharmacists, Eschborn, Germany
CHRISOLDENHOF, PHD
Vice Chairman of the European API Committee of European Chemical Industry Council (CEFIC). and Manager, International Regulatory Affairs, DSWGist-brocades, Delft, Netherlands
Until now, no clear guidance has been available from any authority on a key aspect of drug applications/marketing authorizations, namely, the determination of a suitable starting point for the description of the synthesis of the active pharmaceutical ingredient (API). This paper describes, for the first time, a fully scientifically-based proposal f o r such guidance. It is intended as a recommendation to the International Conference on Harmonization (ICH) expert working group developing guidance with respect to the definition of the “API Starting Material” (APISM) within the Common Technical Document (CTD)initiative. The authors recommend a similar approach to be used in the ICH to define the starting point in the API synthesis, afrer whichfull Current Good Manufacturing Practice (cGMP)principles should apply. Key Words: API; Starting material; ICH; Dossier; GMP
INTRODUCTION IN 1987 THE FIRST was sued by an authority on how to determine what the APISM should be in drug applications. Historically, the most extensive requirements on API process descriptions ex-
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, DSWGist-brocades, Business Group Anti-Infectives, po B~~ 1. 2600 MA Delft, The Netherlands.
isted in the United States but due to the lack of guidance, the approaches used were of a rather ad hoc nature. In Europe, the descript
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