medigraphic.com
ISSN 1561-2988 (Print)

2020, Number 1

<< Back Next >>

Rev Cubana Farm 2020; 53 (1)

Temperature excursions management in the distribution of thermosensitive pharmaceutical products

García GD

Language: Spanish
References: 9
Page: 1-12
PDF size: 193.02 Kb.


ABSTRACT

Introduction: Temperature excursions are a risk in the storage and transportation of thermosensitive products. Inadequate management of distribution channels, when they occur, is a problem that has a negative impact on operations at temperature controlled by Empresa Comercializadora y Distribuidora de Medicamentos [Drug Marketing and Distribution Company].
Objective: To characterize the management of temperature excursions in the distribution of thermosensitive pharmaceutical products in the national supply chain.
Methods: A retrospective-observational study was carried out. The sample consisted of two cold chain break events at Empresa Comercializadora y Distribuidora de Medicamentos, in 2016 and 2017. Bibliographic review and quantitative analysis of variables were applied as techniques.
Results: The insufficient availability of data about stability and the lack of response from suppliers were the causes identified that most make the management of temperature excursions difficult as part of distribution. The opportunity provided by the existing contracts between the suppliers and the distributor to implement improvement actions that mitigate this problem was considered.
Conclusions: The integrative approach in the quality management of the pharmaceutical supply chain, including the management of temperature excursions as part of distribution, is essential to face decision-making with the affected products and avoid the unnecessary elimination of compliant batches, with the considerable losses that this causes to the national economy.


REFERENCES

  1. Kumar N, Jha A. Temperature excursion management: A novel approach of quality system in pharmaceutical industry. Saudi Pharmaceutical Journal. 2017;25:176-83. DOI: http://dx.doi.org/10.1016/j.jsps.2016.07.001

  2. Ammann C. Stability Studies Needed to Define the Handling and Transport Conditions of Sensitive Pharmaceutical or Biotechnological Products. AAPS PharmSciTech. 2011 [acceso 15/01/2019];12(4):1264-75. Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3225534/pdf/12249_2011_Article_9684.p d

  3. Ammann C. Handling Temperature Excursions and the Role of Stability Data. Pharmaceutical OutsourcingTM; 25 sept. 2013. [acceso 15/01/2019]. Disponible en: https://www.pharmoutsourcing.com/Featured-Articles/146648-Handling-Temperature- Excursions-and-the-Role-of-Stability-Data/

  4. World Health Organization. Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products. Technical Report Series No. 961, Annex 9. Geneva: WHO; 2011. [acceso 03/03/2017]. Disponible en: http://www.who.int/medicines/areas/quality_safety/quality_assurance/ModelGuidanceForS torageTransportTRS961Annex9.pdf.

  5. Parenteral Drug Association, Cold Chain Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment. PDA Technical Report 39 (Revised 2007); Supplement Vol. 61, No. S-2; 2007. [acceso 15/01/2019]. Disponible en: https://webstore.ansi.org/standards/pda/pdatr392007

  6. International Conference on Harmonization (ICH) Q1A(R2): Stability Testing of New Drug Substances and Products. Originally published in 1994, revised 2003. [acceso 03/03/2017]. Disponible en: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/QA_R2/ Step4/Q1A_R2__Guideline.pdf.

  7. International Conference on Harmonization (ICH) Q5C: Quality of Biotechnological Products: Stability testing of Biotechnological / Biological products; November 1995. [acceso 03/03/2017]. Disponible en: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5C/St ep4/Q5C_Guideline.pdf

  8. Expert Committee on Specification for Pharmaceutical Preparations, WHO. Technical Report Series No. 1010, 2018, Annex 10: Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. Geneva: WHO; 2018 [acceso 15/01/2019]. Disponible en: https://apps.who.int/medicinedocs/documents/s23498en/s23498en.pdf.

  9. Huq S. Tackling Temperature Excursions: Risks, Challenges and Solutions. Temperature Controlled Logistics; 2018. [acceso 15/01/2019]. Disponible en: https://www.coldchainglobalforumcanada.com/downloads/tackling-temperatureexcursions- risks-challenges-and-solutions




2020     |     www.medigraphic.com