The spplication of PAT for cleaning and cleaning validation

American Pharmaceutical Review

Volumn 11, Issue 4, 2008, Pages

  Hellings, Mario ^a   Vanbaelen, Hilde ^a  

^a Johnson and Johnson ^*

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; CHROMATOGRAPHY; CLEANING; GOOD MANUFACTURING PRACTICE; MEDICAL LITERATURE; REVIEW; TOTAL QUALITY MANAGEMENT; ULTRAVIOLET SPECTROSCOPY; VALIDATION PROCESS;

EID: 55849102100     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (9)

1. U.S. FDA, "Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance", (2004).
2. U.S. FDA, "Guide to Inspections: Validation of Cleaning Processes", (1993).
3. ICH Q7, "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients", (2000).
4. Kaiser H.J. and Minowitz M., "Analyzing Cleaning Validation Samples: What Method?", Journal of Validation Technology, Volume 7, Number 3, (2001).
5. Forsyth, R., "Test method validation for cleaning validation samples", European Pharmaceutical Review Issue 2, (2008).
6. Swartz, M.E., "UPLCTM : An introduction and Review", Journal of Liquid Chromatography & Related technologies 28:7, 1253-1263, (2005).
7. Baumbach, J.I., "Process Analysis using ion mobility spectrometry", Anal. Bioanal. Chem. 384:1059-1070, (2006).
8. Walia G., Davis M., Stefanou S., DeBono R., "Using Ion Mobility Spectrometry for Cleaning Verification in Pharmaceutical Manufacturing", Pharmaceutical technology April 72-74, (2002)
9. Cody R.B., Laramée J.A., Durst H.D., "Versatile new ion source for the analysis of materials in open air under ambient conditions". Anal. Chem. 77 (8): 2297-302, (2005).