| Autor: |
Frank, Ted, Brooks, Stephen, Murray, Kristin, Reich, Steve, Sanchez, Ed, Hasselbaich, Brian, Obeng, Kwame, Creekmore, Richard |
| Předmět: |
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| Zdroj: |
Pharmaceutical Technology; Aug2011, Vol. 35 Issue 8, p72-75, 4p |
| Abstrakt: |
This case study on functional equivalence for equipment replacements is the second of eight in a series put together by the Product 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 and first case study, on defining design space, appeared in the July 2011 issue of Pharmaceutical Technology (1). [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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