Assessment of Regulatory Compliance of Small-Scale Pharmaceutical Manufacturing in Addis Ababa City, Ethiopia
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Date
2020-12
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Addis Abeba University
Abstract
Introduction: There is growing concern that most of the developing world’s supply of
medicines are of poor quality.Manufacturing facilities need to be compliant with
regulatory requirement, which comprises a set of safeguards and procedures at each stage
of the production process to ensure that the manufactured product is of the desired
quality, safety and efficacy.
The aim of this study was to assess regulatory compliance of small-scale pharmaceutical
manufacturing found in Addis Ababa city, Ethiopia.
Method: A cross-sectional observational and questionnaire based study was conducted to
assess regulatory compliance of small-scale local pharmaceutical manufacturing
companies and the major challenges faced by the manufacturing for implementation of
regulatory requirements.
Result:Our study indicated that the overall implementation status of regulatory
requirements in the local pharmaceutical manufacturing companies is far below the
minimum standard set by WHO and national regulatory Authority. From the total
regulatory element requirement only 26.1% were implemented by local small scale
pharmaceutical manufacturers. Major challenges faced by the local small scale
pharmaceutical manufacturing industry for the implementation of regulatory requirement
were: human resource capacity constraints, limited investment, Limited support from
Governments and other stakeholders and poor Infrastructure.
Conclusion: The results of this study will help policy makers and regulatory bodies,
pharmaceutical industries, and other stakeholders to design appropriate interventional
strategy to improve the quality of products in the local pharmaceutical manufacturing
companies.
Recommendation:Government and other stakeholders has a central role to play in
nurturing the infant pharmaceutical industry through support supervision, facilitating
access to technology and business finance, and promoting market access at the national,
regional and international levels.
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Keywords
Pharmaceutical Manufacturing