Abstract
BackgroundQuality by Design (QbD) is a systematic risk-based approach to development, with predefined characteristics and quality risk management throughout the life cycle of a product. International Conference on Harmonization (ICH) guidelines Q8–Q11 give guidance on QbD applications with ICH Q8 (R2)—approved in 2009—describing the principles of QbD in detail. Since its adoption over 10 years ago, more information about QbD usage for the development of medicinal products is expected to be written in regulatory dossiers by companies.MethodsThe present study set out to evaluate the implementation of QbD principles and elements in all EU approved marketing applications (MA) (n = 494), based on information available in the European Public Assessment Reports (EPARs), for a period of six years (2014–2019), starting 5 years after QbD adoption.ResultsOf the 494 MAs, 271 were submitted with a full dossier (article 8(3)). According to EMA (38%), out of the 271 full dossier submissions, only 104 were developed using full QbD. This figure did not increase during this period. Interestingly, between 2014 and 2019, several MAs were not developed via full QbD implementation but used one or more QbD elements during development, including design space. In addition, a higher percentage of small molecule products were developed with QbD as opposed to biotechnology-derived products (78% vs. 22%, respectively).ConclusionOverall, QbD during development of medicinal products is still not commonly described in dossiers. However, more companies started mentioning QbD elements, thus making it a promising step toward QbD as the standard for development in the future.
Highlights
The aim of pharmaceutical development is to create a quality product and its manufacturing process should be designed to consistently deliver the intended performance of the product.Pharmaceutical companies use different strategies for product development: either by taking a conventional approach such as quality by testing, or systematically, such as Quality by Design (QbD), or a combination of both.Zwiers Regulatory Consultancy, Pivot Park, Kloosterstraat 9, 5349AB Oss, The NetherlandsQbD is defined as a systematic risk-based approach for development that begins with predefined objectives
Between 2014 and 2019, several marketing applications (MA) were not developed via full QbD implementation but used one or more QbD elements during development, including design space
The present study aimed to evaluate the information about QbD usage in regulatory dossiers for the development of medicinal products approved in the EU for a period of 6 years, starting 5 years after the adoption date of International Conference on Harmonization (ICH) Q8 (2014–2019)
Summary
Pharmaceutical companies use different strategies for product development: either by taking a conventional approach such as quality by testing, or systematically, such as Quality by Design (QbD) (see Table 1, [1]), or a combination of both. QbD is defined as a systematic risk-based approach for development that begins with predefined objectives. It focuses on product and process understanding and process control, and is based on sound science and quality risk management [2]. Application of QbD principles facilitate development of quality products and their assessment throughout their lifecycle, and result in greater patient benefit [3]. Design (QbD) is a systematic risk-based approach to development, with predefined characteristics and quality risk management throughout the life cycle of a product. Since its adoption over 10 years ago, more information about QbD usage for the development of medicinal products is expected to be written in regulatory dossiers by companies
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