Quality Risk Management of Compliant Excipients

Raw material compliance and GMP do not eliminate variability. Quality by Design should minimize the risk that raw material variability will adversely affect the finished product Critical Quality Attributes. The sources of technological risk from excipients are reviewed and approaches to excipient ri...

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Bibliographic Details
Main Author: Brian Carlin
Format: Article
Language:English
Published: International Pharmaceutical Excipients Council
Series:Journal of Excipients and Food Chemicals
Online Access:http://jefc.scholasticahq.com/article/1104-quality-risk-management-of-compliant-excipients.pdf