Impact of ICH Q11 Questions and Answers on the Outcome of Active Pharmaceutical Ingredient Starting Material Proposal Acceptance by ICH Regulatory Members-Reference-Cited by-同舟云学术

Impact of ICH Q11 Questions and Answers on the Outcome of Active Pharmaceutical Ingredient Starting Material Proposal Acceptance by ICH Regulatory Members

Published:2024-04-29 Issue:7 Volume:28 Page:2590-2607
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Tymonko Steven¹^ORCID,Burke Brenda J.²,Crochard Jean-Philippe³,Dirat Olivier⁴^ORCID,Fraunhoffer Kenneth J.⁵^ORCID,Harrison Cristian⁶,Kramer Timothy⁷,Lee Heewon⁸,Liberman Vlad⁹,Sidhu Kanwar P. S.¹⁰,Smith Randi¹¹,Strotman Neil A.¹²^ORCID,Tandogan Nil¹³,Triman Alan¹⁴,Zhang Haitao¹⁵

Affiliation:

1. CMC Strategy & Portfolio Leadership, AbbVie, North Chicago, Illinois 60046, United States

2. Process Chemistry, Sanofi, Cambridge, Massachusetts 02141, United States

3. Pharma Technical Regulatory, Roche, Basel CH-4070, Switzerland

4. Regulatory CMC, Pfizer Global Product Development, Sandwich CT13 9NJ, United Kingdom

5. Chemical Process Development, Bristol-Myers Squibb, New Brunswick, New Jersey 08901, United States

6. Process Chemistry, Vertex, Boston, Massachusetts 02210, United States

7. Global Statistical Sciences, Eli Lilly and Company, Indianapolis, Indiana 46285, United States

8. Chemical Development, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut 06877, United States

9. Regulatory Affairs CMC, AbbVie, North Chicago, Illinois 60046, United States

10. Quality Department, Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut 06877, United States

11. External Manufacturing, Bristol Myers Squibb, Summit, New Jersey 07901, United States

12. Process Research and Development, Merck & Co., Inc., Rahway, New Jersey 07065, United States

13. Synthetic Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana 46285, United States

14. Drug Substance Regulatory Strategy, Gilead, Foster City, California 94404, United States

15. Chemical Process R&D, Sumitomo Pharma America, Marlborough, Massachusetts 01752, United States

Publisher

American Chemical Society (ACS)

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.4c00033

Reference13 articles.

1. Please visit www.iqconsortium.org for more information.

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

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

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

5. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), 2012. Development and Manufacture of Drug Substance (Chemical Entities and Biotechnological/ Biological Entities (Q11) Retrieved from https://www.ich.org/page/quality-guidelines.