| Autor: |
Frank, Ted, Brooks, Stephen, Murray, Kristin, Reich, Steve, Sanchez, Ed, Hasselbalch, Brian, Obeng, Kwame, Creekmore, Richard |
| Předmět: |
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| Zdroj: |
Pharmaceutical Technology; Jul2011, Vol. 35 Issue 7, p77-79, 3p |
| Abstrakt: |
This case study on defining process design space is the first of eight in a series put together by the Pharmaceutical Quality Research Institute Manufacturing Technology Committee (PQRI-MTC) risk-management working group. The series is meant to advance the understanding and application of the International Conference on Harmonization (ICH) Q9 Quality Risk Management guideline by providing actual examples of risk-management assessments used by the bio/pharmceutical industry. The introductory article appears on page 72 of this issue. The remainder of the case studies will appear in future issues of Pharmaceutical Technology. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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