Are cleanroom regulations realistic?
In: Pharmaceutical Technology Europe, Jg. 22 (2010-12-01), Heft 12, S. 17-18
serialPeriodical
Zugriff:
The article discusses the existing standards for cleanroom operations under the U.S. Food and Drug Administration's (FDA) and European Medicines Agency's (EMA) guidelines. The author offers his views on the factors to be considered before validating a new cleanroom facility. He mentions that the expectations of FDA and EMA in regards to environmental monitoring do not consider the realities of aseptic processing. He adds that there is no assurance on the scientific reality of sterility tests.
Titel: |
Are cleanroom regulations realistic?
|
---|---|
Zeitschrift: | Pharmaceutical Technology Europe, Jg. 22 (2010-12-01), Heft 12, S. 17-18 |
Veröffentlichung: | 2010 |
Medientyp: | serialPeriodical |
ISSN: | 1753-7967 (print) |
Schlagwort: |
|
Sonstiges: |
|