Hari Anand on Quality Assurance and Regulatory Compliance at Africure Pharmaceuticals

In this section of the interview, Hari Anand explains how Africure Pharmaceuticals maintains rigorous quality and regulatory compliance standards throughout its pharmaceutical manufacturing operations. Côte d’Ivoire’s pharmaceutical regulatory authority operates in accordance with World Health Organization standards and imposes strict requirements on pharmaceutical manufacturers. Africure Pharmaceuticals became the first company to receive approval from the country’s new regulatory authority in 2020, following its establishment in 2019.

Quality assurance and quality control are central to the company’s manufacturing processes. Approximately 15 employees are dedicated specifically to these functions, with quality checks carried out at every stage, from the receipt of raw materials through production and packaging to the final delivery of pharmaceutical products.

Hari Anand also outlines the rigorous process required for pharmaceutical product registration. Africure Pharmaceuticals produces three validation batches and conducts six month stability studies, with monitoring continuing for up to two years after production. The resulting data is submitted to the relevant regulatory authorities in each market where the company registers its medicines, including Côte d’Ivoire, Burkina Faso, Benin, and Togo.

Products receive regulatory approval only after laboratory testing confirms that they comply with all required specifications. Through these quality assurance, quality control, stability testing, and regulatory procedures, Africure Pharmaceuticals ensures that its medicines meet the standards required for distribution across its African markets.