An industrial case study: QbD to accelerate time-to-market of a drug product

AAPS Open

Lígia Pedroso Braz¹  José Cardoso Menezes¹  Madalena Testas¹  Anderson Flores²  Silvia Duarte Maia³  Katia Nami Ito Niwa³  Tiago da Cunha Sais³  Leonardo Piccoli Medinilha³  Lucas Sponton de Carvalho³  Cássio Yooiti Yamakawa⁴ 

[1] 4Tune Engineering Lda., Av. António Augusto Aguiar 108-4, 1050-019, Lisbon, Portugal;4Tune Engineering Lda., Brazil Office, Avenida Vereador Narciso Yague Guimarães, 1145; Sala 1008 - Helbor Concept Office, São Paulo, Brazil;Department of Research and Development, Libbs Farmacêutica Ltda, Embu das Artes, SP, Brazil;Department of Research and Development, Libbs Farmacêutica Ltda, Embu das Artes, SP, Brazil;Department of Production, Libbs Farmacêutica Ltda, Embu das Artes, SP, Brazil;

关键词: Pharmaceutical product development;    Quality by design;    Knowledge management;    Quality risk management;    Design of experiments;    Pharmaceutical scale-up;    Control strategy;    Product lifecycle management;   

DOI  :  10.1186/s41120-021-00047-w

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY