A generic HPLC/UV platform method for cleaning verification

American Pharmaceutical Review

Volumn 15, Issue 6, 2012, Pages

  Dong, Michael W ^a   Zhao, Eileen X ^a   Yazzie, Derrick T ^a   Gu, Christine C ^a   Pellet, Jackson D ^a  

^a GENENTECH INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENT; CHEMICALS AND DRUGS; UNCLASSIFIED DRUG;

ANALYTIC METHOD; CLEANING; CONCENTRATION (PARAMETERS); DILUTION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIMIT OF QUANTITATION; QUALITATIVE ANALYSIS; REVIEW; SENSITIVITY ANALYSIS; ULTRAVIOLET SPECTROSCOPY; VALIDATION PROCESS;

EID: 84867750817     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (12)

1. Code of Federal Regulations, Title 21, Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals - Section 67, Equipment cleaning and maintenance (21 CFR 211.67, U.S. Food and Drug Administration, Silver Spring, Maryland, revised April 2011).
2. ICH Harmonised Tripartite Guideline, Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredient, International Conference on Harmonisation, (ICH, Geneva, Switzerland November 2010).
3. Haider, S.I., Asif, E. S., Cleaning Validation Manual: A comprehensive guide for the pharmaceutical and biotechnology industries, (CRC Press, Taylor and Francis, Boca Raton, FL 2010).
4. Pack, B.W., Cleaning verification for highly potent compounds, in Formulation and analytical development for low-dose oral drug product, Zheng, J., ed., (John Wiley & Sons, Hoboken, NJ, 2009).
5. Sharnez. R., Strategies for developing a robust cleaning process: Part 1: application of quality by design to cleaning. Amer. Pharm. Review, 13 (5) (July/August, 2010).
6. Plasz, A. Cleaning validation using HPLC for analysis, in Handbook of pharmaceutical analysis by HPLC, Ahuja, S., Dong, M.W. eds., (Elsevier/Academic Press, Amsterdam, 2005, Chapter 16).
7. Galella, E., Jennings, S., Srikoti, M., Bonasso, E., Cleaning verification: method development and validation using ion mobility spectrometry, Pharm. Tech. 33(7), 60-63 (2009)
8. Liu, L., Pack, B.W., Cleaning verification assays for highly potent compounds by HPLC/MS: strategy, validation and long-term performance, J. Pharma. Biomed. Anal. 43, 1206-1212 (2007).
9. Ruta, J., Zurlino, D., Grivel, C., Heinisch, S., Veuthey, J.-L., Guillarme, D., Evaluation of columns packed with shell particles with compounds of pharmaceutical interest, J. Chromatogr. A, 1228, 221-231 (2012)
10. Dong, M.W., Modern HPLC for Practicing Scientists, Wiley-Interscience, Hoboken, NJ, 2006, Chapters 2, 3, 4 and 8.
11. Rasmussen, H.T., Li, W.Y, Redlich, D, Jimidar, M.I., Method development in early pharmaceutical development, In Handbook of Pharmaceutical Analysis by HPLC, Ahuja, S., Dong, M.W. eds., (Elsevier/Academic Press, Amsterdam, 2005, Chapter 6).
12. Garcia, R., Genentech, private communication, 2012.