Quality by Design for Biopharmaceuticals / Wiley Series on Biotechnology (PDF)

The concepts, applications, and practical issues of Quality by
Design

Quality by Design (QbD) is a new framework currently being
implemented by the FDA, as well as EU and Japanese regulatory
agencies, to ensure better understanding of the process so as to
yield a consistent and high-quality pharmaceutical product. QbD
breaks from past approaches in assuming that drug quality cannot be
tested into products; rather, it must be built into every step of
the product creation process.

Quality by Design: Perspectives and Case Studies presents
the first systematic approach to QbD in the biotech industry. A
comprehensive resource, it combines an in-depth explanation of
basic concepts with real-life case studies that illustrate the
practical aspects of QbD implementation.

In this single source, leading authorities from the
biotechnology industry and the FDA discuss such topics as:

* The understanding and development of the product's critical
quality attributes (CQA)

* Development of the design space for a manufacturing
process

* How to employ QbD to design a formulation process

* Raw material analysis and control strategy for QbD

* Process Analytical Technology (PAT) and how it relates to
QbD

* Relevant PAT tools and applications for the pharmaceutical
industry

* The uses of risk assessment and management in QbD

* Filing QbD information in regulatory documents

* The application of multivariate data analysis (MVDA) to
QbD

Filled with vivid case studies that illustrate QbD at work in
companies today, Quality by Design is a core reference for
scientists in the biopharmaceutical industry, regulatory agencies,
and students.