Assessment of Regulatory Compliance of Small-Scale Pharmaceutical Manufacturing in Addis Ababa City, Ethiopia

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Addis Abeba University


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.



Pharmaceutical Manufacturing