Current Practices of Process Validation for Drug Substances and Intermediates

被引：7

作者：

Anderson, Neal G. ^{[1
]}

Burdick, David C. ^{[2
]}

Reeve, Maxwell M. ^{[3
]}

机构：

[1] Andersons Proc Solut, Jacksonville, OR 97530 USA

[2] Creat Innovat Partners, Albany, NY 12203 USA

[3] Rib X Pharmaceut Inc, New Haven, CT 06511 USA

来源：

ORGANIC PROCESS RESEARCH & DEVELOPMENT | 2011年 / 15卷 / 01期

关键词：

PHARMACEUTICAL-INDUSTRY; ASYMMETRIC-SYNTHESIS; CHEMICAL DEVELOPMENT; INTEGRATED APPROACH; ROUTE; IMPURITIES; OPTIMIZATION; PRODUCTIVITY; SITAGLIPTIN; TECHNOLOGY;

D O I：

10.1021/op1002825

中图分类号：

O69 [应用化学];

学科分类号：

081704 ;

摘要：

Process validation includes laboratory optimization, pilot-plant introduction, and process implementation on manufacturing scale, as well as monitoring batches after implementation and continuously improving the manufacturing processes. There are many opportunities to change and optimize operations. The background information in this contribution describes current guidance and terminology for validation, including the integration of validation over the development lifecycle of drug substances. Various examples illustrate challenges and success stories of implementation as part of the overall approach to process validation.

引用

页码：162 / 172

页数：11

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