| Autor: |
Seltzer, Robert D. |
| Zdroj: |
Journal of GXP Compliance (GXP); Spring2011, Vol. 15 Issue 2, p40-43, 4p, 1 Chart |
| Abstrakt: |
The article discusses the monitoring and testing of bulk pharmaceutical water. The United States Pharmacopeia (USP), PharmEuropa (EP) and the Japanese Pharmacopeia (JP) usually prescribe total organic carbon and water conductivity tests. Particular focus is given to EP's suggested total aerobic microbial count action limit in its water for injection (WFI) monograph, along with existing guides for the frequency and location of bulk pharmaceutical water sampling for monitoring and testing offline. Included is a list of methods for bacterial endotoxin testing allowed by the USP, EP and JP. Information on the implications of pharmaceutical water testing for compliance professionals is also provided. |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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