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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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

Conclusion

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:

References

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here