title: Understanding pharmaceutical quality by design.
abstract: This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA, lawrence.yu@fda.hhs.gov.
authors.forename: Lawrence X
authors.initials: LX
authors.lastname: Yu
authors.forename: Gregory
authors.initials: G
authors.lastname: Amidon
authors.forename: Mansoor A
authors.initials: MA
authors.lastname: Khan
authors.forename: Stephen W
authors.initials: SW
authors.lastname: Hoag
authors.forename: James
authors.initials: J
authors.lastname: Polli
authors.forename: G K
authors.initials: GK
authors.lastname: Raju
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
mesh_terms: D002626:Chemistry, Pharmaceutical; D015195:Drug Design; D004345:Drug Industry; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D058996:Quality Improvement; D013678:Technology, Pharmaceutical
chemical_list: D004364:Pharmaceutical Preparations