Understanding Pharmaceutical Quality by Design
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12248_2014_Article_9598.pdf
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Author(s)
Amidon, Gregory
Polli, James
Woodcock, Janet
Yu, Lawrence X.
Khan, Mansoor A.
Hoag, Stephen W.
Raju, Gokaraju K
Date Issued
May 2014
Journal
The AAPS Journal
Publisher
Springer US
Citation
Yu, Lawrence X., Gregory Amidon, Mansoor A. Khan, Stephen W. Hoag, James Polli, G. K. Raju, and Janet Woodcock. “Understanding Pharmaceutical Quality by Design.” AAPS J 16, no. 4 (May 23, 2014): 771–783.
Version
Author's final manuscript
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.
MIT Department
Massachusetts Institute of Technology. Center for Biomedical Innovation
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Article is made available in accordance with the publisher's policy and may be subject to US copyright law. Please refer to the publisher's site for terms of use.
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DOI of Published Version
https://doi.org/10.1208/s12248-014-9598-3
