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Quality by design (QbD) is an emerging methodology for drug development and manufacturing supported by regulatory bodies in Europe, Asia, and the United States. FDA describes QbD as a "scientific, risk-based, holistic, and proactive approach to pharmaceutical development" that involves a "deliberate design effort from product conception through commercialization" and a "full understanding of how product attributes and process relate to product performance" (Implementing Quality by Design, Helen N. Winkle, September 2007). QbD's guidelines call for companies to provide regulators with better justification and support for the decisions being made across the entire lifecycle of a product/process.

Pharmaceutical Online is pleased to present a new series of guest columns on QbD written by Tim Freeman, director of operations at Freeman Technology. In each installment, Freeman tackles a different topic related to QbD and how it can impact your organization. Following are his columns that have already been published and are now available in Pharmaceutical Online's archives:

Quality By Design: Learning From Experience
While adopting Quality by Design opens the way to increased operational flexibility and efficiency, its achievement requires the pharmaceutical industry to extend its knowledge base, especially in key areas such as powder processing. Within the industry, manufacturing success is usually assured by adhering to detailed procedures, having a formulation that works, rigorously testing in-process material, and perhaps most crucially, drawing on operating expertise developed over the years, tricks that ease the processing of difficult batches.

Identifying CQAs And CPPs: Powder Measurement For QbD
Implementing QbD calls for identification of both critical quality attributes (CQAs) and critical process parameters (CPPs). CQAs are those that impact key aspects of product performance, such as safety, efficacy, and stability. CPPs are the process variables that control CQAs during manufacture. It is clearly essential to accurately define and control both sets of variables, but it also requires detailed knowledge of the process and the product. Acquiring this information can present a challenge, especially for particulate systems; however, modern multifaceted powder characterization can help by providing highly relevant data in a cost-and time-effective way.

Tools For Powder Characterization
The potential benefits of Quality by Design, the approach enshrined in ICH Q8 - Pharmaceutical Development, include greater flexibility with respect to regulation, enhanced process efficiency, and better product understanding. While pharmaceutical manufacturers are keen to access these benefits, there remain some reservations.

Understanding Powders
Effective powder processing underpins almost all pharmaceutical manufacture. The majority of actives are delivered in powder form, as tablets or suspensions, or by dry powder inhaler for example, and even those that aren't are commonly handled as powders at some point during production. A good understanding of powder behavior is therefore essential to implement a knowledge-based approach to development, as advocated by QbD.

Getting To Grips With Quality by Design
Quality by Design (QbD) involves switching from an empirical approach to one based on knowledge, understanding, and sound science. Arguably its most significant impact will be at the development stage when more information will be required to thoroughly map product and process behavior. A better understanding of material properties will be essential and the industry is keen to find tools that will help.

Embracing QbD And PAT
The advent of Quality by Design (QbD) and the Process Analytical Technology (PAT) initiative invites the industry to use its considerable skills to transform process operation and efficiency. One of the keys to this transformation will be a better understanding of powders since almost all pharmaceutical products are handled in this form at some point during manufacture.

About Tim Freeman
Tim Freeman, Director of Operations at Freeman Technology, has created a series of articles relating to the Quality by Design initiative implemented by the company. Tim Freeman has a degree in Mechatronics from the University of Sussex in the UK and has worked for Freeman Technology since the mid 1990s. Since Freeman Technology's launch of the FT4 Powder Rheometer, he has been responsible for application and method development and works closely with customers in the pharmaceutical and powder processing industries.

About Freeman Technology
Freeman Technology was founded in 1988 by Reg Freeman. The company is a specialist company that has pioneered the measurement and understanding of powders and their flow properties. Effective powder processing underpins almost all pharmaceutical manufacture.