Quality by Design: A Contract Organization's Perspective - Pharmaceutical Technology

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Quality by Design: A Contract Organization's Perspective
The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes. This article is part of a special issue on outsourcing.

Pharmaceutical Technology
Volume 36, Issue 8, pp. s20-s26


As pharmaceutical companies partner with CDMOs for development, clinical, and commercial programs, the CDMO will play a critical role in jointly developing a QbD strategy to develop robust processes and quality products. Due to the wealth of knowledge gained by working on multiple, challenging molecules, processes, and products, CDMOs are well positioned to support the sponsor in building a business case, justifying the investment, and applying risk assessment to drive QbD implementation.

Anil Kane, PhD and MBA, is executive director of global science and technology for pharmaceutical development services at Patheon, 2100 Syntex Court, Mississauga, ON L5N 7K9, Canada, tel: 905.812.6874. email:


1. ICH, Q8 Pharmaceutical Development (2009).

2. ICH, Q9 Quality Risk Management (2005).

3. ICH, Q10 Pharmaceutical Quality System (2008).

4. S. Closs, presentation at FDA/Xavier University Global Outsourcing Conference (Cincinnati, OH, 2011).

5. J. Neway, BioPharm Intl. 21 (12), 42–47 (2008).

6. A. Kane, presentation at FDA/Xavier University Global Outsourcing Conference (Cincinnati, OH, 2010).


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