Strengthening the pharmaceutical sector in Ghana

PUM collaborates with the Industrial Support Services Directorate of the Food & Drugs Authority (FDA) in Ghana to provide technical assistance to the pharmaceutical sector toward GMP compliance. Two PUM experts worked hand in hand with eight dedicated FDA employees to elevate the skills and capabilities of local pharmaceutical SMEs. The final goal is to empower these companies, fostering compliance with Good Manufacturing Practices (GMP) and making them competitive players in the African market. This ecosystem approach, in which PUM cooperates with various stakeholders, will be repeated for the cosmetics and food sectors and can also be copied in other countries.

The Food & Drugs Authority (FDA) serves as Ghana’s national regulatory body for food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products, blood and blood products as well as the conduct of clinical trials protocols. In 2019, PUM representative Henrietta Amissah came across an article that mentioned the FDA’s roadmap aimed at supporting Ghana’s pharmaceutical industry in achieving compliance with Good Manufacturing Practices. GMP is a system ensuring consistent production and control of products according to specific quality standards. GMP conformity is necessary to be able to compete with countries like China and India which are currently exporting pharmaceutical drugs to the African markets. The FDA Technical Support Group supports the industry to meet these necessary GMP requirements and enhance the supervisory role of the FDA.

Henrietta explains: “PUM and the FDA have joined forces to create training programmes on Qualification & Validation, provide specialised guidance to companies, and strengthen the FDA’s regulatory capacity. Unlike other international organizations that offered only short-term support, PUM has consistently collaborated with the FDA from 2019 until today. Even during the COVID-19 pandemic, we continued to support the industry by conducting a series of online training sessions.”

Training sessions on qualification & validation

Two PUM experts, Hans Lucas and Jos Kessels, teamed up with eight employees from the FDA to collaboratively develop and deliver seven training modules. These modules were subsequently used to educate the staff of 27 different companies in the pharmaceutical sector. The modules they created cover topics like General Qualification & Validation (Q&V) Principles; Q&V of Facilities, Equipment, and Utilities; and Process, Method, and Cleaning Validation.

The FDA now takes ownership of these training modules, and the eight participating employees have been awarded certificates for their successful completion. Looking ahead, these trained FDA employees will be responsible for conducting the training themselves.

Theory in practice

After completing this first training programme, three PUM experts visited the 27 participating companies to assess if the theory aligns with real-world practice. They compiled reports for each company and documented feedback regarding the training. At the request of the companies visited and in consultation with the FDA, an additional module has been developed about Quality Risk Management. Additionally, efforts were made to engage educational institutes related to the pharmaceutical field to be included in the training programme.

Individual support

Based on the companies’ product portfolio and the overall impression after the above-mentioned visits, seven companies were selected for individual support. Each of them will be assigned a pair of one PUM expert and one FDA employee, who will collaborate with the company on a specific subject. This arrangement allows the FDA employee to gain experience in the consulting work that PUM specialises in.

Building Forward

PUM increasingly works in entrepreneurial ecosystems. PUM sector coordinator ‘Chemical: Pharmaceutical, Herbal & Cosmetic Products’, Edwin Witlox explains: “In this case, the entrepreneurial ecosystem refers to the environment that fosters and supports the growth and success of entrepreneurship within the pharmaceutical sector in Ghana. The ecosystem includes various stakeholders, like the FDA, 27 small and medium enterprises and a possible educational institute. This initiative is replicable, in other sectors and other countries, which will lead to even more sustainable impact.” PUM and the FDA are establishing similar projects for the other two core pillars of FDA: the food and cosmetics sectors. Furthermore, similar programmes have been started in Indonesia and Lebanon, where various associations will serve as a vehicle to reach SMEs in their sectors.”