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...
| Main Author: | |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
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 |
| _version_ | 1797254354891177984 |
|---|---|
| author | Brian Carlin |
| author_facet | Brian Carlin |
| author_sort | Brian Carlin |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T21:48:38Z |
| format | Article |
| id | doaj.art-1567ddb1101146f2a6065043ef018629 |
| institution | Directory Open Access Journal |
| issn | 2150-2668 |
| language | English |
| last_indexed | 2024-04-24T21:48:38Z |
| publishDate | 2016-11-01 |
| publisher | International Pharmaceutical Excipients Council |
| record_format | Article |
| series | Journal of Excipients and Food Chemicals |
| spelling | doaj.art-1567ddb1101146f2a6065043ef0186292024-03-20T18:01:20ZengInternational Pharmaceutical Excipients CouncilJournal of Excipients and Food Chemicals2150-26682016-11-0134Quality Risk Management of Compliant ExcipientsBrian CarlinRaw 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.https://jefc.scholasticahq.com/article/1104-quality-risk-management-of-compliant-excipients |
| spellingShingle | Brian Carlin Quality Risk Management of Compliant Excipients Journal of Excipients and Food Chemicals |
| title | Quality Risk Management of Compliant Excipients |
| title_full | Quality Risk Management of Compliant Excipients |
| title_fullStr | Quality Risk Management of Compliant Excipients |
| title_full_unstemmed | Quality Risk Management of Compliant Excipients |
| title_short | Quality Risk Management of Compliant Excipients |
| title_sort | quality risk management of compliant excipients |
| url | https://jefc.scholasticahq.com/article/1104-quality-risk-management-of-compliant-excipients |
| work_keys_str_mv | AT briancarlin qualityriskmanagementofcompliantexcipients |