Role of quality assurance in Africa’s medicine production

In recent times, poor quality medicines remain a growing issue in low- and middle-income countries (LMICs), especially in sub-Saharan Africa, where it is estimated that they represent 34 percent of the market.

Quality assurance (QA) of pharmaceuticals is a major public health challenge in LMICs, which implies major threats for individual and public health in Africa.

Such products are ineffective, resulting in the growth of drug resistance and prolonged or ineffective treatment for patients, and at worst, they are dangerous, putting lives at risk, even resulting in death.

Africa’s drug industry must therefore strengthen its capacity in pharmaceutical quality assurance to ensure safe medicines for its citizenry.

Implementing quality assurance boosts confidence not only in the current products of a pharmaceutical company but also in its future releases

Pharmaceutical QA is one of the most important aspects of the entire drug manufacturing process. It covers all aspects that could affect the quality of manufactured pharmaceutical products, ensuring that medicines conform to industry standards at all stages of their development, from research to production to final sales.

The purpose of pharmaceutical quality assurance is to ensure that the medication being manufactured will provide the desired effect to the patient. QA also guarantees that there are no contaminants present and that the medications will meet quality requirements and all relevant regulations.

Quality assurance is also essential for pharmaceutical companies, as it helps to protect their reputations, maximise profit, and avoid hefty penalties from regulatory organisations.

A review of the functions of QA is essential to understanding the critical role it plays in strengthening Africa’s drug industry.

Some principal functions of QA in the pharmaceutical industry include: Ensuring the safety of drugs and pharmaceutical products, as products that are defective and non-compliant with pharmaceutical production standards can be potentially dangerous to the patient; ensures that any drug leaving the facility is safe to use and effective for the intended purpose.

For instance, QA ensures drug stability. How well does the drug change over time or when stored in certain conditions, such as temperature or humidity?

Does the chemical or physical make-up of the drug change in a way that renders it unsafe after some time? Pharmaceutical quality assurance aims to generate guidelines for best use and storage practices. This way, customers will not have to worry about a potentially dangerous product.

Ensuring and maintaining compliance with healthcare regulations: Given the tremendous impact of drugs and pharmaceutical products on public health, it’s no surprise that governments are always ready to administer strong penalties and fines for non-compliance with pharmaceutical quality standards.

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QA also ensures the implementation of Good Manufacturing Practices (GMP), helping pharmaceutical firms stay compliant with the stringent regulations of the industry. Regulatory authorities do request inspections and tests to ensure GMP compliance.

Some considerations that pharmaceutical companies must keep in mind are calibrating equipment used in production, maintaining detailed documentation over the process, and testing for quality assurance.

Building and strengthening reputation and consumer trust: The amount of trust patients and customers have in a pharmaceutical company goes hand-in-hand with its legal compliance.

This is because sanctions for poor compliance can become widely known among the public and no one wants to risk personal health on a pharmaceutical manufacturer with a history of poor quality control.

Hence, QA is ultimately a requirement for the long-term success of companies in this industry. Implementing QA boosts confidence not only in the current products of a pharmaceutical company but also in its future releases.

A major challenge confronting the implementation of QA in Africa’s drug industry is the scarcity of trained personnel with the right skill-set in QA within the medicine manufacturing workforce.

Unfortunately, undergraduate pharmacy training does not provide the special skills and know-how needed to fully implement a QA programme in a highly regulated environment as the drug making industry.

To address this deficit in Africa’s drug making workforce, Bloom Public Health strongly proposes to establish a pharmaceutical training academy that will deliver training to new graduates on the continent.

Among other areas, the Academy will impact the needed skills and expertise required to implement QA through all stages of pharmaceutical manufacturing; research to production, final sales and potentially to recall.

Instead of relying on undergraduate education alone, recent graduates will have specific training that teaches them how to test for quality, report issues, and protect the public, providing a ready skilled workforce for pharmaceutical companies.

With the right training, quality assurance professionals will know how to work with the relevant regulatory agencies and conduct inspections at all stages of the manufacturing process.

Given the critical role of QA in the drug-making industry and in protecting public health, African governments and relevant stakeholders must collaborate to develop innovative strategies to strengthen Africa’s capacity in pharmaceutical quality assurance and ensure safe medicines for its populace.