Quality by Design and the Development of Solid Oral Dosage Forms
The intent of this chapter is to provide a high-level overview of the various options available within the QbD tool chest and to describe the benefits derived from adopting a QbD approach to drug product development. This chapter also presents a set of t
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Quality by Design and the Development of Solid Oral Dosage Forms Raafat Fahmy, Douglas Danielson, and Marilyn N. Martinez
Abstract The intent of this chapter is to provide a high-level overview of the various options available within the QbD tool chest and to describe the benefits derived from adopting a QbD approach to drug product development. This chapter also presents a set of terms and definitions that are consistent with ICH Guidelines, practical examples of how QbD can be applied throughout a product life cycle, and the interrelationship between the multiple factors that contribute to product understanding and to the development of product specifications.
Abbreviations API CPP CQA DOE FMEA ICH ISO QbD QRM QTPP MCC MSPC
Active pharmaceutical ingredient Critical process parameter Critical quality attribute Design of experiment Failure modes effect analysis International Conference on Harmonization International Organization for Standardization Quality by design Quality risk management Quality target product profile Microcrystalline cellulose Multivariate statistical process control
R. Fahmy (*) • M.N. Martinez Center for Veterinary Medicine, Office of New Drug Evaluation, Food and Drug Evaluation, Food and Drug Administration, Rockville, MD, USA e-mail: [email protected] D. Danielson Perrigo Company, Allegan, MI, USA M.J. Rathbone and A. McDowell (eds.), Long Acting Animal Health Drug Products: Fundamentals and Applications, Advances in Delivery Science and Technology, DOI 10.1007/978-1-4614-4439-8_7, © Controlled Release Society 2013
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MST NIR PAR PAT PIP PQS RPN RTRT SPC
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R. Fahmy et al.
Material science tetrahedron Near-infrared spectroscopy Proven acceptable ranges Process analytical technology Process-ingredient product diagram Pharmaceutical quality system Risk priority number Real-time release test Statistical process control
Introduction
Quality by design (QbD) has been defined as “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management” (ICH Q8). Despite the innovative aspects of QbD approaches in pharmaceutical product development, the concept of QbD has long been widely applied within such industries as automotive, aviation, petrochemical, and food production. A fundamental goal of drug product development and regulation is to ensure that each marketed lot of an approved product provides its intended in vivo performance characteristics. Globally, regulatory agencies are encouraging the pharmaceutical industry to adopt the QbD concept when developing a new drug product or when improving their legacy drug products. Within the past several years, experts from regulatory authorities within the USA, Europe, and Japan have worked together under the umbrella of International Conference for Harmonization (ICH) to establish a basis for applying these concepts. Ultimately, the use of QbD provides an understanding of the drug product based on
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