Part 1: A Review and Perspective of the Regulatory Guidance to Support Designation and Justification of API Starting Material

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• 作者：Margaret M. Faul ; William F. Kiesman ; Maciej Smulkowski ; Steven Pfeiffer ; Carl A. Busacca ; Magnus C. Eriksson ; Fred Hicks ; John D. Orr
• 刊名：Organic Process Research & Development
• 出版年：2014
• 出版时间：May 16, 2014
• 年：2014
• 卷：18
• 期：5
• 页码：587-593
• 全文大小：205K
• 年卷期：v.18,no.5(May 16, 2014)
• ISSN：1520-586X

文摘

Designation and justification of active pharmaceutical ingredient starting material (API SM) is a standard part of the drug substance (DS) development and commercialization process. However, current industry practices are not well understood and vary, depending on the individual company鈥檚 interpretation of regulatory guidelines. In addition, regulators are also applying varying interpretations to the designation of API SMs, further complicating progress in this arena. To increase the understanding of the strategies employed in selection and justification of API SMs the authors, members of the API and Analytical Leadership Groups of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), completed a broad industry survey of this topic among the 35 IQ Consortium member companies. To put the results of this survey into context, an understanding of the historical development of API SM regulations and the industry perspective is important and is summarized collectively for the first time in this manuscript (Part 1). The detailed results of the survey are summarized and published in a second manuscript (Part 2; Designation and Justification of API Starting Materials: Current Practices across Member Companies of the IQ Consortium). Part 3 of this series is expected to be published in the future and will outline opportunities to improve the process in alignment with Q11.