Evidence map›Paper›PMID 28923044›Full record

ArticleBMC health services research2017

Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

Chimezie Anyakora, Obinna Ekwunife, Faith Alozie, Mopa Esuga, Jonathan Ukwuru, Steve Onya, Jude Nwokike

Abstract read
In one paragraph

Article in BMC health services research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Moving beyond a legacy paradigm: A vision for equitable access to quality medicines in Africa.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Chimezie AnyakoraPromoting the Quality of Medicines Program, U.S. Pharmacopeial Convention, Rockville, MD, USA. CZA@usp.org.
Obinna EkwunifeDepartment of Clinical Pharmacy and Pharmacy Management, Nnamdi Azikiwe University, Awka, Nigeria.
Faith AlozieThe Centre for Applied Research on Separation Science Lagos, Lagos, Nigeria.
Mopa EsugaPromoting the Quality of Medicines Program, U.S. Pharmacopeial Convention, Rockville, MD, USA.
Jonathan UkwuruPromoting the Quality of Medicines Program, U.S. Pharmacopeial Convention, Rockville, MD, USA.
Steve OnyaChi Pharmaceuticals Limited, Lagos, Nigeria.
Jude NwokikePromoting the Quality of Medicines Program, U.S. Pharmacopeial Convention, Rockville, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPharmaceutical 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.

methodThe 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).

resultCost 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).

conclusionInvestment 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.

Indexed as

Cost-Benefit AnalysisQuality ControlCertificationDrug IndustryInvestmentsNigeriaPharmaceutical PreparationsQuality ImprovementWorld Health OrganizationZinc SulfatePharmaceutical PreparationsZinc SulfateAfricaCost-benefit analysisGood manufacturing practiceNigeriaPharmaceutical companiesPrequalification

Identifiers

PMID28923044
PMCPMC5604295

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.