Quality by design, Nigeria’s key to global pharma space – Onyewuenyi

Nonye Onyewuenyi, PhD, is the CEO and Chief Scientific Officer of Noniks Analytics, USA. A pharmaceutical scientist and global programme management executive, her scientific expertise spans the full translational continuum of drug product development, from pre-formulation science, formulation design, and optimisation, to analytical chemistry. With over two decades of experience, she was a featured speaker at the recently concluded 29th Annual Conference of the Association of Industrial Pharmacists of Nigeria (NAIP), titled “Harmony Reloaded 2026,” held in Ilorin, Kwara State, Nigeria. Dr Onyewuenyi is a strong proponent of Quality-by-Design (QbD) as the essential translational bridge between pharmaceutical science and manufacturing reality

In this insightful interview with Temitope Obayendo, she simplifies the key messages from her two presentations at the conference, emphasising that local pharmaceutical manufacturers in Nigeria must embrace Quality by Design (QbD) as a prerequisite for competing globally. She laments the current state of local drug manufacturing, noting that despite having more than 120 registered manufacturers, the country still produces less than 30 per cent of its drug requirements, which she describes as a failure of formulation science and capability. She also discusses the role of artificial intelligence and machine learning in pharmaceutical manufacturing, as well as the challenge of financing facility upgrades required for WHO prequalification. Excerpts:

You delivered two presentations during the NAIP Harmony Reloaded 2026 conference. Could you summarise the main themes of the first presentation and what you hoped attendees would take away?

It was a privilege to be part of such a landmark gathering for the Nigerian pharmaceutical community. My first presentation, titled Principles of Drug Formulation and Design, was structured around one overarching conviction: that formulation science, strongly supported by Quality by Design (QbD) and Process Analytical Technology (PAT), is not a downstream activity; rather, it is the most critical strategic investment the Nigerian pharmaceutical industry can make right now.

The presentation opened with a deliberate overview of the Nigerian pharmaceutical landscape. With approximately 70 per cent of medicines imported, an annual pharmaceutical import bill exceeding $2 billion, and a population of more than 200 million people, the urgency is clear. Nigeria has over 120 registered manufacturers, yet local production satisfies less than 30 per cent of national demand. That gap is not primarily a policy failure; it is a failure of formulation science and capability.

From there, I took participants through the foundations of drug formulation, from pre-formulation science and active pharmaceutical ingredient (API) characterisation to excipient design, Biopharmaceutics Classification System (BCS) strategy, routes of administration, drug-release mechanisms and the five-stage formulation development process. A major theme throughout was the Quality by Design framework, as defined under ICH Q8(R2), together with Analytical Quality by Design (AQbD), because quality cannot simply be tested into a product; it must be designed into it from the beginning.

I also devoted considerable attention to artificial intelligence and machine learning in pharmaceutical manufacturing, explaining what they are, why they matter and how they can benefit Nigerian manufacturers. The average cost of drug development is about $2.6 billion, while 90 per cent of drug candidates fail in clinical trials. The session concluded with a discussion on locally sourced excipients. Nigeria’s rich agricultural resources, ranging from cassava starch to palm-derived lubricants, present a genuine competitive advantage that remains largely untapped.

The key message I wanted attendees to take away is that formulation excellence is not a luxury reserved for well-funded multinationals. It is the discipline that determines whether a Nigerian-manufactured medicine reaches patients and works effectively. Every regulatory submission, shelf-life decision and tablet-coating choice is fundamentally a formulation decision, and Nigerian scientists are fully capable of making world-class ones.

Moving to your second presentation, what were the key arguments or data points you shared, and how did they complement the first?

My second presentation was a dedicated deep dive into Quality by Design. While the first presentation established the “what” and “why” of formulation science, the second focused entirely on the “how”, specifically how to build pharmaceutical quality in a rigorous, defensible and internationally recognised manner.

The central argument was straightforward: QbD is no longer optional for manufacturers that aspire to compete beyond Nigeria’s borders. NAFDAC and international regulatory agencies, including WHO, the USFDA and the EMA, increasingly require QbD-style submissions. More importantly, QbD reduces costly product failures by an estimated 40 to 60 per cent, which is transformative for lean Nigerian manufacturers that cannot afford excessive waste.

I explained the QbD architecture, beginning with the Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), linking Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs), establishing the design space and implementing a control strategy supported by PAT. I also discussed the parallel AQbD framework, which applies the same principles to analytical methods, ensuring that measurements remain accurate, validated and legally defensible throughout a product’s life cycle.

I linked QbD directly to the ICH Q8, Q9, Q10 and Q11 guidelines, demonstrating how these internationally harmonised standards form the scientific foundation of world-class pharmaceutical development programmes. I also shared case studies based on WHO prequalification rejections and NAFDAC dossier deficiencies to illustrate the consequences of poor QbD implementation.

The two presentations were designed to complement each other. The first built scientific understanding, while the second focused on operational capability and regulatory readiness.

The mini-workshop focused on WHO prequalification. Why is this topic crucial for local pharmaceutical manufacturers right now?

WHO prequalification is, in many respects, the ultimate quality benchmark for pharmaceutical products intended for public health markets. It provides access to United Nations agencies, global health initiatives and export opportunities across Africa and beyond. For Nigerian manufacturers, achieving WHO prequalification is not merely a badge of honour; it is a strategic and commercial necessity.

The timing is particularly important. West Africa’s pharmaceutical market is projected to exceed $4 billion by 2030, and Nigeria must position itself as a net supplier rather than a net importer. The African Continental Free Trade Area presents a tremendous opportunity for Nigerian-manufactured medicines to reach 54 countries, but this can only happen if quality standards are internationally recognised. Likewise, NAFDAC’s regulatory reforms and alignment with WHO standards increasingly favour manufacturers that build quality into their products from the outset.

The workshop centred on a frank assessment of where Nigerian manufacturers currently fall short. The major gaps are not scientific capability, but weaknesses in documentation, data integrity, dossier completeness and sustained quality systems. The ALCOA+ principles – Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available – are indispensable, yet failures in data integrity remain among the most common reasons for rejection.

I also highlighted the importance of credible laboratories as the foundation for AI-enabled and internationally recognised quality systems. Manufacturers cannot build credible regulatory dossiers on data generated from laboratories lacking Good Laboratory Practice accreditation or validated methods. The pathway I outlined was simple: build credible laboratories, ensure data integrity, digitise records, leverage artificial intelligence and machine learning, and then pursue WHO prequalification. All these begin with applying Quality by Design from the earliest stages of drug formulation.

Aside from knowledge gaps in documentation for WHO prequalification, a major challenge for most local manufacturers is funding. How can they bridge this gap?

This is perhaps the most practical and pressing question, and it deserves a frank answer. Funding is a genuine challenge, but it is not insurmountable. Sometimes, it is used as a reason to postpone actions that can be implemented immediately without significant capital.

There are two dimensions to the issue. The first involves activities that require little or no new investment. Documentation reform, data integrity, standard operating procedures, staff training in GMP and QbD principles, and digitisation of batch records are all achievable immediately. Yet these are precisely the areas in which WHO prequalification applications most often fail.

The second dimension involves capital-intensive requirements such as facility upgrades, analytical instrumentation, environmental controls and manufacturing equipment. Fortunately, several funding avenues exist. The Central Bank of Nigeria operates intervention funds to support pharmaceutical manufacturing. Manufacturers should prepare robust business cases and pursue these opportunities. WHO and UNIDO also support manufacturers in developing countries through technical assistance and, in some cases, infrastructure support. Institutions such as the African Development Bank and the Gates Foundation have substantial investments in pharmaceutical manufacturing across sub-Saharan Africa and could support well-structured, QbD-aligned proposals.

Another underutilised option is collaboration among industry, academia and government. Universities provide scientific expertise, manufacturers contribute facilities and production data, while government offers grants. Such models have succeeded in countries such as India, Brazil and South Africa, and there is no reason they cannot work in Nigeria.

Equipment leasing is another practical solution. Manufacturing and analytical equipment do not always have to be purchased outright. Leasing arrangements are becoming increasingly available in Nigeria, making advanced technology more accessible.

Ultimately, the real question is not whether manufacturers can afford to pursue WHO prequalification, but whether they can afford not to. Achieving WHO prequalification opens the door to United Nations procurement contracts, development agency tenders and export markets that far exceed the opportunities available in the domestic market. The return on investment is substantial and measurable.