Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer
Abstract Background Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalificatio...
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| Format: | Article |
| Language: | English |
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BMC
2017-09-01
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| Series: | BMC Health Services Research |
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| Online Access: | http://link.springer.com/article/10.1186/s12913-017-2610-8 |
| _version_ | 1818316026430881792 |
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| author | Chimezie Anyakora Obinna Ekwunife Faith Alozie Mopa Esuga Jonathan Ukwuru Steve Onya Jude Nwokike |
| author_facet | Chimezie Anyakora Obinna Ekwunife Faith Alozie Mopa Esuga Jonathan Ukwuru Steve Onya Jude Nwokike |
| author_sort | Chimezie Anyakora |
| collection | DOAJ |
| description | Abstract Background Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. Method The cost benefit of improving the quality of Chi Pharmaceuticals Limited’s facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Result Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0–5.5). Conclusion Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa. |
| first_indexed | 2024-12-13T09:14:53Z |
| format | Article |
| id | doaj.art-94b21760112e4046bfd085e293054bcf |
| institution | Directory Open Access Journal |
| issn | 1472-6963 |
| language | English |
| last_indexed | 2024-12-13T09:14:53Z |
| publishDate | 2017-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Health Services Research |
| spelling | doaj.art-94b21760112e4046bfd085e293054bcf2022-12-21T23:52:51ZengBMCBMC Health Services Research1472-69632017-09-011711910.1186/s12913-017-2610-8Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturerChimezie Anyakora0Obinna Ekwunife1Faith Alozie2Mopa Esuga3Jonathan Ukwuru4Steve Onya5Jude Nwokike6Promoting the Quality of Medicines Program, U.S. Pharmacopeial ConventionDepartment of Clinical Pharmacy and Pharmacy Management, Nnamdi Azikiwe UniversityThe Centre for Applied Research on Separation Science LagosPromoting the Quality of Medicines Program, U.S. Pharmacopeial ConventionPromoting the Quality of Medicines Program, U.S. Pharmacopeial ConventionChi Pharmaceuticals LimitedPromoting the Quality of Medicines Program, U.S. Pharmacopeial ConventionAbstract Background Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. Method The cost benefit of improving the quality of Chi Pharmaceuticals Limited’s facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Result Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0–5.5). Conclusion Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.http://link.springer.com/article/10.1186/s12913-017-2610-8AfricaCost-benefit analysisGood manufacturing practiceNigeriaPharmaceutical companiesPrequalification |
| spellingShingle | Chimezie Anyakora Obinna Ekwunife Faith Alozie Mopa Esuga Jonathan Ukwuru Steve Onya Jude Nwokike Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer BMC Health Services Research Africa Cost-benefit analysis Good manufacturing practice Nigeria Pharmaceutical companies Prequalification |
| title | Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer |
| title_full | Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer |
| title_fullStr | Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer |
| title_full_unstemmed | Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer |
| title_short | Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer |
| title_sort | cost benefit of investment on quality in pharmaceutical manufacturing who gmp pre and post certification of a nigerian pharmaceutical manufacturer |
| topic | Africa Cost-benefit analysis Good manufacturing practice Nigeria Pharmaceutical companies Prequalification |
| url | http://link.springer.com/article/10.1186/s12913-017-2610-8 |
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