An industrial case study: QbD to accelerate time-to-market of a drug product
Madalena Testas, Tiago da Cunha Sais, Leonardo Piccoli Medinilha, Katia Nami Ito Niwa, Lucas Sponton de Carvalho, Silvia Duarte Maia, Anderson Flores, Lígia Pedroso Braz, José C. Menezes, Cassio Yooiti Yamakawa
Abstract
Abstract The use of a Quality by Design (QbD) approach in the development of pharmaceutical products is known to bring many advantages to the table, such as increased product and process knowledge, robust manufacturing processes, and regulatory flexibility regarding changes during the commercial phase. However, many companies still adhere to a more traditional pharmaceutical process development—in some cases due to the difficulty of going from a theoretical view of QbD to its actual application. This article presents a real-world case study for the development of an industrial pharmaceutical drug product (oral solid dosage form) using the QbD methodology, demonstrating the activities involved and the gains in obtaining systematic process and product knowledge.