A Practical Guide to Quality by Design (QbD) for Pharmaceutical Product Development

March 1, 2018 Suzanne Konigsberg

By:  Mustafa A. Zaman, Principal Consultant, &  Siegfried Schmitt, Principal Consultant, PAREXEL Consulting

Pharmaceutical Quality by Design: A Practical Approach is due for publication on 9th March 2018. The book outlines a practical, yet innovative approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry globally. The text explores the innovative approach to product development, and is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product.

The book takes a practical approach and focuses on the industrial aspects of QbD, and covers Quality Risk Management Tools and Analysis, Applications of QbD to Analytical Methods, Regulatory Aspects, Quality Systems and Knowledge Management. Furthermore, the book explores the development and manufacture of drug substances and products, and considers the Design of Experiments (DoE), the role of excipients, Multivariate Analysis, and includes several examples of applications of QbD in actual practice.

Given the importance of this new paradigm, PAREXEL Consulting includes dedicated subject-matter experts with significant experience in this area (including two consultants who have contributed to the book) who are specifically suited to advise pharmaceutical companies (of all sizes) on how to plan, forge strategies for and implement QbD.

PAREXEL is currently supporting clients in assessing their manufacturing capabilities and is developing regulatory strategies for a variety of small molecule and large molecule products in order to best explore this innovative approach to product development.

[Siegfried Schmitt has written Chapter 3: Quality Systems and Knowledge Management

Mustafa A. Zaman and Siegfried Schmitt have co-written Chapter 12: Regulatory Guidance



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