ISO 9001:2015 & ISO 27001:2022 Certified Organization
In a strategic initiative during 2022 to strengthen pharmaceutical manufacturing capacities across COVID-19-impacted countries, we led the development of a Regional GMP Scheme aimed at elevating 10 pharmaceutical enterprises in the COMESA region. Supported by the African Development Bank (AfDB), this project was designed to align with WHO’s Current Good Manufacturing Practices (cGMP), Quality Management Systems (QMS), and regional standards to ensure global competitiveness and regulatory compliance.
As part of this initiative, we designed and developed a comprehensive GMP Scheme based on the latest WHO cGMP standards, laying the foundation for a high-quality, efficient, and globally recognized pharmaceutical manufacturing framework. To ensure regional collaboration and stakeholder engagement, we organized a virtual validation workshop, bringing together key decision-makers, including government agencies, pharmaceutical industry leaders, and regulatory authorities, to review and refine the proposed roadmap.
To drive data-backed decision-making, we conducted in-depth empirical assessments of 10 selected pharmaceutical enterprises across COMESA Member States, identifying strengths and areas for improvement to facilitate targeted support under the GMP Scheme. Recognizing the importance of capacity building, we organized national training workshops to equip these enterprises with the knowledge and tools needed for effective GMP implementation.
A critical component of this initiative was conducting on-site production assessments, where we evaluated the compliance of these enterprises against 17 key quality parameters of WHO cGMP standards and QMS requirements. These assessments provided actionable insights to ensure that the region's pharmaceutical manufacturers meet the highest global quality and safety standards.
Through this transformative initiative, we are not only contributed for strengthening the pharmaceutical manufacturing landscape in COMESA countries but also fostering innovation, regulatory excellence, and global market competitiveness. This project marks a significant step toward a more resilient, self-sufficient, and high-quality pharmaceutical industry, ensuring better healthcare outcomes for the region.