Abstract
Since the roll out of ICH Q8, Q9, and Q10 documents and FDA drafted a QbD CMC review MaPP (MAPP 5016.1), the regulatory agencies expect and encourage the pharmaceutical/biopharmaceutical industry the use of QbD in drug applications as implementation of QbD will enhance the assurance of pharmaceutical quality in the market and improve the quality of CMC information submitted. It is believed to be a win-win situation for both industry and regulators as it ensures less IRs (information request) during the review, speeds up approval process, and provides flexibility to make changes within the design spaces while providing a quality product with a better design with fewer problems in manufacturing resulting in reduction in overall costs of manufacturing, and creates less waste. This chapter describes how QbD elements—risk assessment, process characterization, and design space—can be applied to design, develop, and scale-up and control the lyophilization process.
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Acknowledgment
We would like to acknowledge Abe Germansderfer for his valuable insights and contributions.
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Appendix (Table 18)
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Jameel, F. (2023). Application of QbD Elements in the Development and Manufacturing of a Lyophilized Product. In: Jameel, F. (eds) Principles and Practices of Lyophilization in Product Development and Manufacturing . AAPS Advances in the Pharmaceutical Sciences Series, vol 59. Springer, Cham. https://doi.org/10.1007/978-3-031-12634-5_23
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