Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium

被引：122

作者：

Allison, Gretchen ^{[1
]}

Cain, Yanxi Tan ^{[2
]}

Cooney, Charles ^{[3
]}

Garcia, Tom ^{[4
]}

Bizjak, Tara Gooen ^{[5
]}

Holte, Oyvind ^{[6
]}

Jagota, Nirdosh ^{[7
]}

Komas, Bekki ^{[8
]}

Korakianiti, Evdokia ^{[9
]}

Kourti, Dora ^{[10
]}

Madurawe, Rapti ^{[5
]}

Morefield, Elaine ^{[11
]}

Montgomery, Frank ^{[12
]}

Nasr, Moheb ^{[13
]}

Randolph, William ^{[14
]}

Robert, Jean-Louis ^{[15
]}

Rudd, Dave ^{[9
]}

Zezza, Diane ^{[16
]}

机构：

[1] Pfizer, Kalamazoo, MI USA

[2] Novartis Pharma AG, Basel, Switzerland

[3] MIT, Cambridge, MA 02139 USA

[4] Pfizer, Groton, CT USA

[5] US FDA, Silver Spring, MD USA

[6] Norwegian Med Agcy, Oslo, Norway

[7] Roche Pharma, Basel, Switzerland

[8] GlaxoSmithKline, Res & Dev, Res Triangle Pk, NC USA

[9] EMA, London, England

[10] GSK, Global Mfg & Supply, Ware, Herts, England

[11] Vertex Pharmaceut Inc, Pharmaceut Dev, Boston, MA USA

[12] Astrazeneca, Global Med Dev, Macclesfield SK10 2NA, Cheshire, England

[13] GlaxoSmithKline, Res & Dev, Collegeville, PA 19426 USA

[14] J&J, Janssen, Janssen Supply Grp, New Brunswick, NJ USA

[15] Natl Hlth Lab, Luxembourg, Luxembourg

[16] Novartis Pharmaceut, E Hanover, NJ USA

来源：

JOURNAL OF PHARMACEUTICAL SCIENCES | 2015年 / 104卷 / 03期

关键词：

continuous manufacturing; GMP; ICH; regulatory considerations; validation; control strategy; unit operations; stability; processing; bioequivalence;

D O I：

10.1002/jps.24324

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. (c) 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:803-812, 2015

引用

页码：803 / 812

页数：10