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 |
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| creator | Balogh, Michael P Corbin, Virginia L |
| description | 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). |
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| identifier | ISSN: 1753-7967 |
| ispartof | Pharmaceutical technology Europe, 2005-03, Vol.17 (3), p.44 |
| issn | 1753-7967 |
| language | eng |
| recordid | cdi_proquest_journals_211393095 |
| source | Business Source Complete; EZB-FREE-00999 freely available EZB journals |
| subjects | 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 |
| title | Taming the regulatory beast: regulation versus functionalism |
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