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Journal of Spectroscopy
Volume 2015, Article ID 847349, 8 pages
Research Article

Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method

1oncomed manufacturing a.s., Karásek 1229/1b, 62100 Brno, Czech Republic
2Department of Chemical Drugs, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Palackého 1-3, 61242 Brno, Czech Republic

Received 9 May 2015; Revised 24 June 2015; Accepted 25 June 2015

Academic Editor: Jeongkwon Kim

Copyright © 2015 Zuzana Slivová and Radka Opatřilová. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. G. Fourman and M. Mullen, “Determining cleaning validation acceptance limits for pharmaceutical manufacturing operations,” Pharmaceutical Technology, vol. 17, no. 4, pp. 54–60, 1993. View at Google Scholar
  2. PDA, “Points to consider for cleaning validation,” Tech. Rep. 29, 1998. View at Google Scholar
  3. Pharmaceutical Inspection Convention, “Recommendations on validation master plan, installation and operational qualification, non-sterile process validation, cleaning validation,” Tech. Rep. PI 006-3, 2007. View at Google Scholar
  4. European Chemical Industry Council/Active Pharmaceutical Ingredients Committee, Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants, APIC, 2000.
  5. Health Products and Food Branch Inspectorate, Cleaning Validation Guidelines (GUIDE-0028), 2008.
  6. World Health Organization, “Appendix 3 cleaning validation in: annex 4 supplementary guidelines on good manufacturing practices: validation,” Technical Report Series 937, World Health Organization, 2006. View at Google Scholar
  7. US Food and Drug Administration (FDA); Office of Regulatory Affairs, “Guide to inspections validation of cleaning processes 7/29,” Cleaning Validation Guidelines (GUIDE-2008), US Food and Drug Administration (FDA), Office of Regulatory Affairs, Washington, DC, USA, 2011. View at Google Scholar
  8. E. Chu and A. C. Sartorelli, “Cancer chemotherapy,” in Basic and Clinical Pharmacology, B. G. Katzung, Ed., pp. 949–975, McGraw-Hill, New York, NY, USA, 12th edition, 2012. View at Google Scholar
  9. R. Hrdina, V. Gersl, I. Klimtová, T. Simůnek, J. Machácková, and M. Adamcová, “Anthracycline-induced cardiotoxicity.,” Acta Medica, vol. 43, no. 3, pp. 75–82, 2000. View at Google Scholar · View at Scopus
  10. J. M. Horacek, R. Pudil, L. Jebavy, M. Tichy, P. Zak, and J. Maly, “Assessment of anthracycline-induced cardiotoxicity with biochemical markers,” Experimental Oncology, vol. 29, no. 4, pp. 309–313, 2007. View at Google Scholar · View at Scopus
  11. J. M. Horacek, M. Vasatova, M. Tichy, R. Pudil, L. Jebavy, and J. Maly, “The use of cardiac biomarkers in detection of cardiotoxicity associated with conventional and high-dose chemotherapy for acute leukemia,” Experimental Oncology, vol. 32, no. 2, pp. 97–99, 2010. View at Google Scholar · View at Scopus
  12. J. Hartl, M. Doležal, M. Miletín et al., Pharmaceutical Chemistry IV, Charles University, Prague, Czech Republic, 2006.
  13. O. O. Shevchuk, E. A. Posokhova, L. A. Sakhno, and V. G. Nikolaev, “Theoretical ground for adsorptive therapy of anthracyclines cardiotoxicity,” Experimental Oncology, vol. 34, no. 4, pp. 314–322, 2012. View at Google Scholar · View at Scopus
  14. T. Šimůnek, M. Štěrba, O. Popelová, M. Adamcová, R. Hrdina, and V. Gerši, “Anthracycline-induced cardiotoxicity: overview of studies examining the roles of oxidative stress and free cellular iron,” Pharmacological Reports, vol. 61, no. 1, pp. 154–171, 2009. View at Publisher · View at Google Scholar · View at Scopus
  15. A. Walsh, “Cleaning validation for the 21st century: acceptance limits for active pharmaceutical ingredients (APIs): Part I,” Pharmaceutical Engineering, vol. 31, no. 4, pp. 78–83, 2011. View at Google Scholar · View at Scopus
  16. ICH, “ICH harmonised tripartite guideline, Q2A, text on validation of analytical procedures,” in Proceedings of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, October 1994.