Quality-by-Design Principles Applied to the Establishment of a Pharmaceutical Quality Control Laboratory in a Resource-Limited Setting: The Lab Water

Quality-by-design (QbD) is defined as a systematic approach to design and develop a product/service based on sound science and quality risk management. It is already frequently applied in the pharmaceutical industry mainly in the development of pharmaceutical products and analytical methods but is not well established in the setup of facilities like quality control (QC) laboratory (lab). Therefore, lab QbD (lQbD) concept is introduced considering lab water purification system as an example. The water purification system comprising distillation unit coupled with Nanopure Analytical Ultrapure Water System combined with a 0.2-micron filter was established in Jimma University Laboratory of Drug Quality (JuLaDQ). The consistent capability of the established water purification system was evaluated through routine monitoring of the critical quality parameters (i.e., physicochemical, HPLC-DAD chromatogram total peak area, and resistivity) of freshly prepared lab water for a period of one year. In addition, quality of different grade water (tap water, distilled water (before and/or after cleaning distillation unit), and fresh ultrapure water (18.2 MΩ × cm at 25°C)) used in JuLaDQ was evaluated. The results of routine analysis of water quality revealed that HPLC global peak area at 210 and 254 nm could serve as one of the discriminatory control strategies to evaluate the capability of water purification system to produce the desired quality of lab water; and thus, we proposed a specification limit of 5,000 mAU∗s and 5,500 mAU∗s for global peak area at 254 and 210 nm, respectively, as system suitability parameter.

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A narrative review on problems in product quality, regulatory system constraints, and the concept of quality by design as a solution for quality assurance of African medicines

Hassen,

Mekasha,

Tegegne

et al. 2024

Front. Med.

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BackgroundThe provision of medicines with confirmed quality and efficacy is critical for maintaining the public health and building confidence in the healthcare systems. However, the presence of poor-quality medicines still presents a significant challenge in the pharmaceutical landscape across the African regions. This is further exacerbated by the lack of consistency or discrepancy in the current regulatory framework. As a consequence, given the current constraints, a robust regulatory structure that can guarantee the supply chains attainment of the intended medicinal product requirements are required.ObjectiveThe review aimed to provide a detailed analysis of the quality issues in the pharmaceutical supply in Africa, highlighting the challenges and proposing potential solutions for its mitigation.MethodsThe review was conducted from May 2023 to April 2024. This narrative review examined poor-quality medicines, regulatory challenges, and mitigation strategies in the African pharmaceutical industry. The review utilized databases such as Google Scholar, PubMed, and Web of Science. The search strategy was customized to include open-access articles published in peer-reviewed scientific journals in English and focused exclusively on studies conducted in African countries.ResultsThe review portrays the prevalence of poor-quality medicinal products in various regions of Africa. Among various categories of findings, 42% of the reports on poor-quality medicinal products come from the African region, as per the WHO report. Furthermore, separate findings on substandard medicinal products from many African countries were encountered. The presence of problems in the regulatory system, such as the absence of any pharmacopeia belonging to any African country and variation/inconsistency in each country’s regulatory set-up, was indicated. Other factors for the inability to enforce regulatory law, such as insufficient skilled and committed human resources, the presence of corruption, as well as financial resource scarcity, were revealed in the review. From the situational analysis, the possibility of building a robust quality assurance system in the near future through a quality by design approach under existing resource limitations was discussed.ConclusionThe pharmaceutical sector in Africa faces significant challenges, including the prevalence of poor-quality medicines and weak regulatory enforcement. Tackling these challenges are vital for enhancing health outcomes throughout the continent through the provision of high-quality medicines. Trending toward quality by design in the quality assurance system under prevailing financial scarcity can be very beneficial.

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Quality-by-Design Principles Applied to the Establishment of a Pharmaceutical Quality Control Laboratory in a Resource-Limited Setting: The Lab Water

Cited by 3 publications

References 19 publications

Introduction: Quality Assurance from Perspective of Pharmaceutical Industry

Introduction: Quality Assurance from Perspective of Pharmaceutical Industry

Quality-by-Design Principles Applied to the Establishment of a Pharmaceutical Quality Control Laboratory in a Resource-Limited Setting: The Lab Water

A narrative review on problems in product quality, regulatory system constraints, and the concept of quality by design as a solution for quality assurance of African medicines

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