Part 3: Designation and Justification of API Starting Materials: Proposed Framework for Alignment from an Industry Perspective-Reference-Cited by-同舟云学术

Part 3: Designation and Justification of API Starting Materials: Proposed Framework for Alignment from an Industry Perspective

Published:2015-06-15 Issue:8 Volume:19 Page:915-924
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Faul Margaret M.¹,Argentine Mark D.²,Egan Marjorie³,Eriksson Magnus C.⁴,Ge Zhihong⁵,Hicks Fred⁶,Kiesman William F.⁷,Mergelsberg Ingrid⁵,Orr John D.⁸,Smulkowski Maciej⁹,Wächter Gerald A.¹⁰

Affiliation:

1. Process Development, Amgen Inc., Thousand Oaks, California 91320, United States

2. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, United States

3. Infinity Pharmaceuticals, 780 Memorial Drive, Cambridge, Massachusetts 02139, United States

4. Chemical Development, Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut 06877, United States

5. Merck & Co., Inc. Merck Research Laboratories, 126 East Lincoln Avenue, Rahway, New Jersey 07065, United States

6. Takeda Pharmaceuticals International Company, Cambridge, Massachusetts 02139, United States

7. Chemical Process Research & Development, Biogen, Cambridge, Massachusetts 02142, United States

8. Analytical Research Laboratories US, Pharm. Sci. & Tech., Eisai Inc., Andover, Massachusetts 01810, United States

9. Chicago Pharmaceutical Science Group, Takeda Development Center Americas, Inc., Deerfield, Illinois 60015, United States

10. Launch and Transfer Drug Substance, Boehringer Ingelheim Pharma GmbH & Co. KG, 55216 Ingelheim, Germany

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.5b00079

Reference14 articles.

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

2. Part 2: Designation and Justification of API Starting Materials: Current Practices across Member Companies of the IQ Consortium

3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q11, May 2012.

4. European Directorate for the Quality of Medicines and Healthcare Certification of Substances Division. “Top Ten Deficiencies: New Applications for Certificates of Suitability”, June 2012.

5. European Medicines Agency (EMA/448443/2014) CHMP and CVMP “Reflection Paper on theRequirements for the Selection and Justification of Starting Materialsfor the Manufacture of Chemical Active Substances”, September (2014.

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