| Autor: |
Richard K. Burdick, Fuat Doymaz, Frank Ye |
| Rok vydání: |
2015 |
| Předmět: |
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| Zdroj: |
Quality by Design for Biopharmaceutical Drug Product Development ISBN: 9781493923151 |
| DOI: |
10.1007/978-1-4939-2316-8_26 |
| Popis: |
This chapter provides a guideline for assessing the ability to manufacture homogeneous drug product batches during validation of commercial drug product manufacturing processes that span formulation, fill, and finish steps. A stepwise approach that specifies activities involved in different phases of these activities is explained with an illustration on a simulated dataset. Results clearly demonstrate the utility of the framework for robust assessment of the process capability to manufacture homogeneous drug product and for generating a robust data package for drug product filing purposes. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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