Amongst low- and middle-income countries worldwide, the African region has the highest prevalence of poor-quality medicines with an 18.7% prevalence of substandard and falsified medicines. These challenges have, in part, been attributed to Africa’s poor local manufacturing capacity and weak compliance of local manufacturers with Good Manufacturing Practices (GMP).
In Africa, very few local manufacturers have reached international standards of quality. In most pharmaceutical companies, the conditions are very unsatisfactory, with poor quality of both the individual production sites and the quality management systems. The consequence of this is the possibility of poor quality medicines in the supply chain.
It is therefore critical that African pharmaceutical manufacturers take proactive steps to guarantee their products are safe and effective, thus ensuring an optimal availability of high-quality medicines across the continent. To achieve this, African local pharmaceutical companies need to meet the rules of Good Manufacturing Practice (GMP) as promulgated by their respective National Medicines Regulatory Authorities (NMRAs).
Compliance with GMP has a direct impact on the quality of pharmaceutical products. Poor quality medicines are not only a health hazard, but also a waste of money
Good Manufacturing Practice (GMP) – importance and benefits
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards, fit for their intended use, comply with the requirements of the marketing authorisations, and do not place the populace at risk. GMP is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. It covers all aspects of production, from the starting materials, premises, and equipment, to the training, documentation and personal hygiene of staff.
Why is GMP important?
Compliance with GMP has a direct impact on the quality of pharmaceutical products. Poor quality medicines are not only a health hazard, but also a waste of money. Implementation of GMP by local pharmaceutical manufacturers is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the African pharmaceutical industry and health professionals.
GMP also helps boost the pharmaceutical export opportunities of African pharmaceutical companies. Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. African governments can therefore promote their countries’ export of pharmaceuticals by making GMP mandatory for all pharmaceutical production.
Challenges and strategies to strengthen GMP compliance in Africa’s pharmaceutical industry
The pharmaceutical manufacturing industry in Africa faces a plethora of challenges that compromise quality management systems and compliance with Good Manufacturing Practices. Major challenges include weak or absent policies and regulatory systems, a lack of competent regulatory inspectors in NMRAs, high cost of upgrading factories and hiring or training qualified professional, lack of technical support and limited expertise of local manufacturers, amongst others.
Tackling the above challenges is critical to improve compliance with GMP standards and ensure production of quality medicines and pharmaceutical products in Africa. In view of these, Bloom Public Health recommends the following strategies:
1. Increased investment in African local manufacturers: African governments need to invest more in local manufacturers both financially and by providing technical support to meet regulatory standards. This can be achieved by leveraging on the expertise of the private sector through strategic public-private partnerships. A good example is the partnership between Bloom Public Health and Nigeria’s National Institute for Pharmaceutical Research and Development.
In the World Bank-funded initiative, NIPRD and Bloom Public Health have begun a project to support selected Nigerian pharmaceutical manufacturers towards the attainment of WHO PQ of their products. Through this project, Bloom Public Health will provide full technical support for the selected companies, including accessing gaps in the companies’ technical capacities and quality management systems using internationally accepted regulatory standards, and inspection of the corresponding manufacturing sites to ensure conformity with WHO Good Manufacturing Practices (GMP).
2. Strengthening NMRAs’ capacity through training of regulatory personnel: NMRAs play a critical role in implementing GMP standards by pharmaceutical manufacturers. Unfortunately, the capacity of African NMRAs is hampered by the shortage of personnel to perform critical regulatory functions, including insufficient qualified assessors and inspectors. African governments, therefore, need to provide relevant training to build a critical mass of regulatory inspectors that are well-trained in GMP requirements. NMRAs can also take advantage of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) membership to build the capacity of its inspectors as promoted by the Africa-wide PIC/S Initiative.
3. Compliance training for company staff: Compliance training helps staff gain a better understanding of GMP and continually improves operations or systems in place to ensure standards are GMP-compliant. All employees should receive training on record-keeping, sanitation, proper equipment handling, and labelling, and SOPs to minimise errors and maintain compliance.
4. Leveraging technological advancement for automation of GMP processes: Recent technologies provide robust processes and easy-to-use systems that enforce and monitor standards to strengthen GMP compliance of organisations. Digital tools such as mobile inspection apps, GMP software, and sensors can bring better operational management and guarantee full control over the production process.
In conclusion, GMP compliance is crucial in the pharmaceutical manufacturing industry to guarantee quality-assured products that secure the health and safety of the public. More efforts are therefore needed to strengthen quality management systems and GMP compliance of Africa’s local pharmaceutical manufacturers.