An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan
Abstract 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 pha...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-04-01
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| Series: | Cost Effectiveness and Resource Allocation |
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| Online Access: | https://doi.org/10.1186/s12962-022-00348-1 |
| _version_ | 1818774274836529152 |
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| author | Rohullah Roien Rajeev Shrestha Kashikant Yadav Akihiko Ozaki M. Bashir Ahmadi Yudai Kaneda Yasuhiro Kotera Binaya Sapkota Sunil Shrestha |
| author_facet | Rohullah Roien Rajeev Shrestha Kashikant Yadav Akihiko Ozaki M. Bashir Ahmadi Yudai Kaneda Yasuhiro Kotera Binaya Sapkota Sunil Shrestha |
| author_sort | Rohullah Roien |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-18T10:38:33Z |
| format | Article |
| id | doaj.art-f2886c74fd114c2ea5a0f289c1b319f7 |
| institution | Directory Open Access Journal |
| issn | 1478-7547 |
| language | English |
| last_indexed | 2024-12-18T10:38:33Z |
| publishDate | 2022-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Cost Effectiveness and Resource Allocation |
| spelling | doaj.art-f2886c74fd114c2ea5a0f289c1b319f72022-12-21T21:10:42ZengBMCCost Effectiveness and Resource Allocation1478-75472022-04-012011910.1186/s12962-022-00348-1An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, AfghanistanRohullah Roien0Rajeev Shrestha1Kashikant Yadav2Akihiko Ozaki3M. Bashir Ahmadi4Yudai Kaneda5Yasuhiro Kotera6Binaya Sapkota7Sunil Shrestha8Medical Research Centre, Kateb UniversityDepartment of Pharmacy, District Hospital LamjungDepartment of Research and Development, Samar Pharma Company Pvt. Ltd.Medical Governance Research InstituteAfghanistan Pharmacists AssociationHokkaido University School of MedicineFaculty of Medicine and Health Sciences, University of NottinghamDepartment of Pharmaceutical Sciences, Nobel College, Affiliated to Pokhara UniversityDepartment of Pharmaceutical and Health Service Research, Nepal Health Research and Innovation FoundationAbstract 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.https://doi.org/10.1186/s12962-022-00348-1AfghanistanGood manufacturing practiceLow-income countriesPharmaceutical Industry |
| spellingShingle | Rohullah Roien Rajeev Shrestha Kashikant Yadav Akihiko Ozaki M. Bashir Ahmadi Yudai Kaneda Yasuhiro Kotera Binaya Sapkota Sunil Shrestha An assessment of adherence to the WHO-delineated good manufacturing practice by the pharmaceutical companies in Kabul, Afghanistan Cost Effectiveness and Resource Allocation Afghanistan Good manufacturing practice Low-income countries Pharmaceutical Industry |
| 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 | Afghanistan Good manufacturing practice Low-income countries Pharmaceutical Industry |
| url | https://doi.org/10.1186/s12962-022-00348-1 |
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