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AAPS PharmSciTech

, Volume 12, Issue 4, pp 1264–1275 | Cite as

Stability Studies Needed to Define the Handling and Transport Conditions of Sensitive Pharmaceutical or Biotechnological Products

Review Article

Abstract

Many pharmaceutical or biotechnological products require transport using temperature-controlled systems to keep their therapeutic properties. There are presently no official guidelines for testing pharmaceutical products in order to define suitable transport specifications. After reviewing the current guidance documents, this paper proposes a methodology for testing pharmaceutical products and defining appropriate transport conditions.

Key words

biotechnological products distribution pharmaceutical products stability temperature excursions transport 

Notes

Acknowledgment

The author would like to acknowledge Dr. Manuel Zahn, Managing Director, 3R Pharma Consulting GmbH, Dr Steve Butcher and Dr Eugene Helsel, Senior Director, Quality, Stemedica Cell Technologies, Inc., San Diego, CA, for reviewing the article and their very appreciated and friendly support.

References

  1. 1.
    Stability testing of new drug substances and products—Q1A (R2). (ICH), International Conference on Harmonization. Originally published 1994, revised 2003.Google Scholar
  2. 2.
    Stability testing: photostability testing of new drug substances and products—Q1B. (ICH), International Conference on Harmonization. 6 November 1996.Google Scholar
  3. 3.
    Stability testing for new dosage forms—Q1C. (ICH), International Conference on Harmonization. 6 November 1996.Google Scholar
  4. 4.
    Bracketing and matrixing designs for stability testing of new drug substances and products—Q1D. (ICH), International Conference on Harmonization. 7 February 2002.Google Scholar
  5. 5.
    Evaluation for stability data—Q1E. (ICH), International Conference on Harmonization. 6 February 2003.Google Scholar
  6. 6.
    Quality of biotechnological products: stability testing of biotechnological/biological products—Q5C. (ICH), International Conference on Harmonization. 30 November 1995.Google Scholar
  7. 7.
    Technical Report Series, No. 953: Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. WHO. 2009.Google Scholar
  8. 8.
    US Pharmacopoeia. USP. current version.Google Scholar
  9. 9.
    Technical Report no. 39: Cold chain guidance for medicinal products: maintaining the quality of temperature-sensitive medicinal products through the transportation environment. PDA. Originally published 2005, revised 2007.Google Scholar
  10. 10.
    Technical Report no. 46: Last mile: guidance for good distribution practices for pharmaceutical products to the end user. PDA. 2009.Google Scholar
  11. 11.
    Temperature controlled pharmaceutical distribution maintaining the quality of temperature sensitive products in the supply chain. Representative, FDA. Hotel Fira Palace, Barcelona: IBC Informa life sciences, 26–29 September 2006.Google Scholar
  12. 12.
    Temperature Controlled Pharmaceutical Distribution Conference. Representative, FDA. Amsterdam: IBC Informa life sciences, 9–10 October 2007.Google Scholar
  13. 13.
    Seevers RH, Bishara RH, Harber PJ, Lucas TI. Designing stability studies for time/temperature exposure. American Pharmaceutical Outsourcing. 2005; 6(5): 18, 20, 21, 23, 55Google Scholar
  14. 14.
    Lucas TI, Bishara RH, Seevers RH. A stability program for the distribution of drug products. pp. 68–73, s.l.: Pharmaceutical Technology, July 2004.Google Scholar
  15. 15.
    Guidelines for selecting and using ISTA test procedures and projects. ISTA. current.Google Scholar
  16. 16.
    International standards. ASTM. current.Google Scholar
  17. 17.
    Perishable cargo regulations, chapter 17 9th edition. IATA. July 2009.Google Scholar
  18. 18.
    Ammann Claude. A mathematical approach to assessing temperature excursions in temperature-controlled chains. European Journal of Parenteral and Pharmaceutical Sciences. 2008;13(2):57–9.Google Scholar
  19. 19.
    Handbook of stability testing in pharmaceutical development regulations, methodologies, and best practices. Huynh-Ba, Kim (Ed.). s.l.: Springer, 2009.Google Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2011

Authors and Affiliations

  1. 1.Claude Ammann ConsultingEpalingesSwitzerland

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