Taming the regulatory beast: regulation versus functionalism

Taming the regulatory beast: regulation versus functionalism

Current regulations (21 CFR 211) address mass spectrometers and their use. Though the instruments do not require special testing, they must be properly calibrated and maintained - demonstrably fit for their intended use (21 CFR 211.67).The regulations also specify that only qualified personnel perfo...

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Veröffentlicht in:Pharmaceutical technology Europe 2005-03, Vol.17 (3), p.44
Hauptverfasser: Balogh, Michael P, Corbin, Virginia L
Format: Artikel
Sprache:eng
Schlagworte:
21st century
Compliance
Documentation
Federal regulation
Food additives
Good Manufacturing Practice
Laboratories
Manufacturing
Mass spectrometry
Pharmaceutical industry
Product recalls
Quality control
Regulated industries
Regulation
Risk assessment
Science
Scientists
Software
Training
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Zusammenfassung:Current regulations (21 CFR 211) address mass spectrometers and their use. Though the instruments do not require special testing, they must be properly calibrated and maintained - demonstrably fit for their intended use (21 CFR 211.67).The regulations also specify that only qualified personnel perform the work (21 CFR 211.25), that they use appropriately designed equipment and software (21 CFR 211.63) and that all operations take place inside a suitable facility (21 CFR 211.42 - 211.58).
ISSN:1753-7967