Regulatory Compliance of Small-Scale Pharmaceutical manufacturing facilities in Addis Ababa, Ethiopia

Abstract

Background: there is growing concern that medicines supplied to most of the developing countries are of substandard quality. Along with the establishment of strong regulatory systems for ensuring compliance and regulatory law enforcement, manufacturing facilities need to work to implement dependable systems at each stage of the production process to ensure the safety, efficacy, and quality of their products. Objective: the aim of this study was to assess the level of compliance with regulatory requirements by small-scale pharmaceutical manufacturing facilities in Addis Ababa, Ethiopia.
 Material & Method: A cross-sectional observational study was conducted using a structured questionnaire and checklist to assess the level of compliance of small-scale local pharmaceutical manufacturing facilities to regulatory requirements and also to identify the challenges faced by the manufacturing facilities.
 Result: This study indicated that the overall implementation status of regulatory requirements in the local small-scale pharmaceutical manufacturing companies is far below the minimum standard set by WHO and the national regulatory authority. Basic on specific regulatory requirement elements compliance: requirements related to QA were 26.9, requirements related to personnel qualification were 38.1, requirements related to Quality control were 25.9, and requirements related to sanitation and hygiene were 15.3. Of the total regulatory requirements, only 26.1% were found to be implemented. Major challenges faced by the local small-scale pharmaceutical manufacturing industry for the implementation of regulatory requirements were: human resource capacity constraints, limited investment, limited support from Governments and other stakeholders, and poor infrastructure.
 Conclusion: The study demonstrated that level of regulatory requirements implementation in the local small-scale pharmaceutical manufacturers is far below the minimum standard set by the national regulatory authority. Important gaps were reported particularly in materials management, production operations, quality control, and sanitation and hygiene.