Literature DB >> 34763368

Quality assessment of cold chain storage facilities for regulatory and quality management compliance in a developing country context.

Otuto Amarauche Chukwu1,2, Maxwell Adibe1.   

Abstract

BACKGROUND: Supply chain management is essential for cold chain medicines since they are temperature-controlled and must be maintained within a specific temperature range to ensure product integrity and quality. In Nigeria, guidelines that address drug distribution do not adequately address the issue of cold chain management in addition to challenges in implementation. Given the chaotic medicines distribution system, this study examined the quality of practice of supply chain management of cold chain products in line with the World Health Organisation's Expert Committee report on Specifications for Pharmaceutical Preparations.
METHODS: The study was set in Abuja Nigeria and descriptive survey was used to explore cold chain supply management. A checklist developed from regulatory requirements stipulated by the World Health Organisation covering documentations, storage and distribution guidelines was used to assess supply chain management of cold chain medicines across various facilities. Data were analysed using IBM Statistical Package for the Social Sciences (SPSS) version 25.
RESULTS: The results from this study showed that most of the storage facilities assessed (66.7%) did not meet up to the required standards of quality management for cold chain products. In addition, 50.4% of retail and hospital pharmacy facilities performed poorly in cold chain management practices. Many of aspects of quality management guidelines and regulations were not met by the facilities. Most facilities (66.7%) do not have their equipment calibrated, 43.6% of the hospital and retail pharmacies assessed do not have an automated system to cater for power failure while 37.6% do not perform a temperature check on cold chain products before receiving from suppliers.
CONCLUSION: The study has shown that the levels of the supply chain assessed for quality management and regulatory compliance performed poorly. There was limited availability and use of validated quality monitoring systems for cold chain medicines in these facilities.
© 2021 John Wiley & Sons Ltd.

Entities:  

Keywords:  cold chain; developing country; quality assessment; regulatory compliance; storage

Mesh:

Year:  2021        PMID: 34763368     DOI: 10.1002/hpm.3385

Source DB:  PubMed          Journal:  Int J Health Plann Manage        ISSN: 0749-6753


  2 in total

1.  Quality Risk Management Algorithm for Cold Storage Construction Based on Bayesian Networks.

Authors:  Yaping Song; Zhanguo Wei
Journal:  Comput Intell Neurosci       Date:  2022-06-24

2.  Supporting the pandemic response and timely access to COVID-19 vaccines: a case for stronger priority setting and health system governance in Nigeria.

Authors:  Otuto Amarauche Chukwu; Lydia Kapiriri; Beverley Essue
Journal:  Int J Pharm Pract       Date:  2022-06-25
  2 in total

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