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
2016-11-01
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| Series: | Journal of Excipients and Food Chemicals |
| Online Access: | https://jefc.scholasticahq.com/article/1104-quality-risk-management-of-compliant-excipients |
| Summary: | 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 risk management are discussed. Supplier involvement throughout the product life-cycle is recommended to minimize excipient-related risk. |
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| ISSN: | 2150-2668 |