Assessment of current good manufacturing practice (cGMP) compliance in pharmaceutical manufacturers in Ethiopia: Cross-sectional descriptive study

BACKGROUND: The distribution of low-quality medications poses a serious risk to public health, especially in underdeveloped nations like Ethiopia. Ineffective use of Current Good Manufacturing Practices (cGMP) increases these dangers, which include cross-contamination, mix-ups, and incorrect labeling. To ensure consistent product quality and adherence to set standards, a Pharmaceutical Quality System (PQS) that effectively integrate cGMP is essential. Assessing cGMP compliance is essential for the reliable production of safe pharmaceuticals. OBJECTIVE: This study aims to assess cGMP compliance in Ethiopian pharmaceutical manufacturers. METHODS: A cross-sectional descriptive design was employed for this study. The data collection process involved a checklist for field observations and, interview-based questions. The checklist, developed based on WHO GMP requirements, was filled through direct site observations, document reviews, and discussions with key persons in the appropriate departments. The study included six companies located in Addis Ababa and its surrounding areas. The qualitative data were transformed into quantitative data through coding and categorization for easier analysis. The data were then analyzed using descriptive statistics, cross-tabulation, and other statistical tests with SPSS software version 28. The results were displayed using data visualization tools like tables and graphs. RESULTS: The study revealed overall cGMP compliance rates of 62.8%, 85.84%, 84.95%, 86.72%, 84.95%, and 84.1% for companies 1-6, respectively. All companies had some degree of GMP non-conformity; however, only Company 1 had critical deviations. The GMP standards were well-maintained by the remaining five companies. Company 1 has to make improvements in several areas, most notably its QA systems. Additionally, Companies 1, 5, and 6 must improve their QRM systems. Company 5 needs to improve its production process, while Companies 1, 2, and 3 should focus on better managing their equipment and materials. CONCLUSION AND RECOMMENDATION: This study evaluated GMP compliance levels across six pharmaceutical manufacturers in Ethiopia. Most of the assessed companies showed a satisfactory degree of GMP compliance. To improve compliance, minimize risks, and ensure product quality, safety, and operational efficiency, the study suggested strengthening risk mitigation measures such as raising employees' knowledge and training.