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An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan

BACKGROUND: Afghanistan, a low-income landlocked country, is continuously suffering from domestic war and conflicts; the country struggles to provide quality healthcare services, including affordable medicinal products in the required quantity. Moreover, the quality standards of domestic pharmaceuti...

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Autores principales: Roien, Rohullah, Shrestha, Rajeev, Yadav, Kashikant, Ozaki, Akihiko, Ahmadi, M. Bashir, Kaneda, Yudai, Kotera, Yasuhiro, Sapkota, Binaya, Shrestha, Sunil
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8977029/
https://www.ncbi.nlm.nih.gov/pubmed/35366905
http://dx.doi.org/10.1186/s12962-022-00348-1
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author Roien, Rohullah
Shrestha, Rajeev
Yadav, Kashikant
Ozaki, Akihiko
Ahmadi, M. Bashir
Kaneda, Yudai
Kotera, Yasuhiro
Sapkota, Binaya
Shrestha, Sunil
author_facet Roien, Rohullah
Shrestha, Rajeev
Yadav, Kashikant
Ozaki, Akihiko
Ahmadi, M. Bashir
Kaneda, Yudai
Kotera, Yasuhiro
Sapkota, Binaya
Shrestha, Sunil
author_sort Roien, Rohullah
collection PubMed
description BACKGROUND: Afghanistan, a low-income landlocked country, is continuously suffering from domestic war and conflicts; the country struggles to provide quality healthcare services, including affordable medicinal products in the required quantity. Moreover, the quality standards of domestic pharmaceutical companies have not been established yet. One of the internationally recognized guidelines for monitoring manufacturing processes in pharmaceutical companies is Good Manufacturing Practice (GMP), recommended by World Health Organization (WHO). Therefore, this study aimed to assess whether a pharmaceutical company in Kabul, Afghanistan adheres to the GMP standards established by WHO. METHOD: A descriptive cross-sectional study was conducted to assess the WHO-delineated GMP compliance of 25 pharmaceutical companies in Kabul, Afghanistan. The inspection checklist was developed by Afghanistan's National Medicine and Healthcare Products Regulatory Authority (NMHRA) using the WHO-delineated GMP guidelines. In addition, direct observation, interviews with respective delegates, and documentation reviews were conducted to collect research data. RESULT: Only 38.33% (1.14 ± 1.08) of GMP contents were complied. Personnel 66.67% (2 ± 1.15) and materials 58.67% (1.76 ± 1.11) were the most commonly complied components, whereas the product recall 12.98% (0.39 ± 0.85), quality assurance 16.44% (0.49 ± 0.81) and quality control laboratory 28.35% (0.85 ± 1.12) were the least complied ones. CONCLUSION: None of the GMP components was fully adhered to by the pharmaceutical companies in Kabul, Afghanistan. Quality control and assurance should be implemented immediately, including validation and qualification practices. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12962-022-00348-1.
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spelling pubmed-89770292022-04-04 An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan Roien, Rohullah Shrestha, Rajeev Yadav, Kashikant Ozaki, Akihiko Ahmadi, M. Bashir Kaneda, Yudai Kotera, Yasuhiro Sapkota, Binaya Shrestha, Sunil Cost Eff Resour Alloc Research BACKGROUND: Afghanistan, a low-income landlocked country, is continuously suffering from domestic war and conflicts; the country struggles to provide quality healthcare services, including affordable medicinal products in the required quantity. Moreover, the quality standards of domestic pharmaceutical companies have not been established yet. One of the internationally recognized guidelines for monitoring manufacturing processes in pharmaceutical companies is Good Manufacturing Practice (GMP), recommended by World Health Organization (WHO). Therefore, this study aimed to assess whether a pharmaceutical company in Kabul, Afghanistan adheres to the GMP standards established by WHO. METHOD: A descriptive cross-sectional study was conducted to assess the WHO-delineated GMP compliance of 25 pharmaceutical companies in Kabul, Afghanistan. The inspection checklist was developed by Afghanistan's National Medicine and Healthcare Products Regulatory Authority (NMHRA) using the WHO-delineated GMP guidelines. In addition, direct observation, interviews with respective delegates, and documentation reviews were conducted to collect research data. RESULT: Only 38.33% (1.14 ± 1.08) of GMP contents were complied. Personnel 66.67% (2 ± 1.15) and materials 58.67% (1.76 ± 1.11) were the most commonly complied components, whereas the product recall 12.98% (0.39 ± 0.85), quality assurance 16.44% (0.49 ± 0.81) and quality control laboratory 28.35% (0.85 ± 1.12) were the least complied ones. CONCLUSION: None of the GMP components was fully adhered to by the pharmaceutical companies in Kabul, Afghanistan. Quality control and assurance should be implemented immediately, including validation and qualification practices. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12962-022-00348-1. BioMed Central 2022-04-02 /pmc/articles/PMC8977029/ /pubmed/35366905 http://dx.doi.org/10.1186/s12962-022-00348-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Roien, Rohullah
Shrestha, Rajeev
Yadav, Kashikant
Ozaki, Akihiko
Ahmadi, M. Bashir
Kaneda, Yudai
Kotera, Yasuhiro
Sapkota, Binaya
Shrestha, Sunil
An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan
title An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan
title_full An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan
title_fullStr An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan
title_full_unstemmed An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan
title_short An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan
title_sort assessment of adherence to the who-delineated good manufacturing practice by the pharmaceutical companies in kabul, afghanistan
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8977029/
https://www.ncbi.nlm.nih.gov/pubmed/35366905
http://dx.doi.org/10.1186/s12962-022-00348-1
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