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