Spectroscopy, 2022-09, Vol.37 (9), p.8-14
2022
Volltextzugriff (PDF)
Details
- Autor(en) / Beteiligte
- Titel
- Quo Vadis Analytical Procedure Development and Validation?
- Ist Teil von
- Spectroscopy, 2022-09, Vol.37 (9), p.8-14
- Ort / Verlag
- Monmouth Junction: Intellisphere, LLC
- Erscheinungsjahr
- 2022
- Quelle
- EZB Electronic Journals Library
- Beschreibungen/Notizen
- What do the draft publications ICH Q2(R2) and Q14 for analytical procedure validation and development mean for a regulated Good Manufacturing Practice (GMP) laboratory? Are they consistent with the approach taken by United States Pharmacopoeia (USP) on Analytical Procedure Lifecycle? Why does it take two documents to describe what USP can do in one?
- Sprache
- Englisch
- Identifikatoren
- ISSN: 0887-6703eISSN: 1939-1900DOI: 10.56530/SPECTROSCOPY.MF9790D5Titel-ID: cdi_proquest_reports_2818985664
- Format
- –
- Schlagworte
- Analytical methods, CFR, Good Manufacturing Practice, Government regulation, Instruments (Equipment), International conferences, Laboratories, Laws, regulations and rules, Mathematical analysis, Methods, Pharmaceutical industry, Physical instruments, Procedures, Process control, Process controls, Quality control, Regulation, Risk management, Science, Sound