Validation Case Study: Erroneous Negative Cleaning Validation Results.
This case study describes a cleaning validation event in which failing results for API residue from a small molecule extended release tablet dosage form were observed. The initial two lots in the cleaning validation were successful. The third lot failed acceptable residue limits. Investigation of th...
| Publicado en: | Journal of Validation Technology (JVT) Vol. 22; no. 5; pp. 3 - 10 |
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| Autor principal: | |
| Formato: | Journal Article |
| Publicado: |
Institute of Validation Technology
2016
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| Acceso en línea: | Ver este registro en EBSCOhost |