| Autor: |
Dennis, Jenke, Steve, Swanson, Eric, Edgcomb, Tom, Couch, Molly, Chacko, Mary Jo, Garber, Liqiong, Fang |
| Rok vydání: |
2006 |
| Předmět: |
|
| Zdroj: |
PDA journal of pharmaceutical science and technology. 59(6) |
| ISSN: |
1079-7440 |
| Popis: |
Container/closure systems are extensively characterized in terms of their propensity to contribute leachable substances to the drug products they contain. Such a characterization is relevant until a change occurs in the composition or production of the container/closure system itself or the raw materials it is comprised of. When such a change occurs, it is necessary to ascertain the impact that the change would have on the validity and applicability of the previously performed leachables assessment. A general methodology for performing change control evaluations is developed in this manuscript and is illustrated via the use of a case study. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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