| Summary: | This paper discusses the challenges and advantages of implementing Quality by Design (QbD) and Question based Review (QbR) when developing solid dosage formulations and manufacturing processes for generic drugs. Formulation and process development of a drug product is challenging due to the inherent variability of the processes. Regulatory agencies, such as the Food and Drug Administration (FDA) in the USA, demand a QbD approach when developing formulations and processes for new and existing medicinal products. The QbD approach is described in the International Conference on Harmonization (ICH) Guidance Q8 (R2). The regulatory reviewers follow the QbR approach during the review of Chemistry, Manufacturing, and Controls (CMC), which have also adopted some of the elements of the QbD guidance. A systematic application of scientific principles for developing the formulations and processes for generic drug products following the QbD approach is outlined below in three main categories. The categories are product understanding, process understanding, and control strategy. The concept of predefined objectives, quality risk management, and CMC considerations together with the prior knowledge are discussed in detail. The discussions and explanations provided in this paper are based on sound scientific principles, as well as, practical experience applied to resolve product quality and manufacturing issues. Emphasis is given to streamlining formulation and process development that complies with current QbD and QbR principles in order to prevent commonly
cited deficiencies. Examples are provided as guiding tools for generic formulation and process development.
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