The ultimate goal of QbD has been summarized in a statement from Janet Woodcock, director of the Center for Drug Evaluation
and Research (CDER) at FDA, who suggested during a ISPE and AAPS-sponsored CMC workshop on Oct. 5, 2005, that a mutual goal
of industry, society, and regulators is "a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably
produces high-quality drug products without extensive regulatory oversight." To achieve this goal, it is crucial that we move
from a checkbox, compliance-focused culture to one that is founded on a science- and risk-based approach to assure quality
The authors would like to acknowledge the support of the Parental Drug Association and the assistance of Georg Roessling,
senior vice-president PDA Europe; Susanne Keitel, director of European Directorate for the Quality of Medicines; and Jean
Louis Robert, chair of the EMA Quality Working Party in helping organize and facilitate the workshop.
1. ICH, Q8 Pharmaceutical Development (R2) (August 2009).
2. ICH, Q9 Quality Risk Management (November 2005).
3. ICH, Q10 Pharmaceutical Quality System (June 2008).
4. ICH, Q11 Development and Manufacture of Drug Substances (May 2012).
5. M. Schweitzer et al., Pharm. Technol. 34 (2), 52–59 (2010).
6. FDA, Guidance for Industry, Process Validation: General Principles and Practices, Revision 1 (January 2011).
7. EMA, Note for Guidance on Process Validation (EMA/CHMP/CVMP/QWP/70278/2012-Rev1).
8. FDA, Guidance for Industry, PAT–A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance (September 2004).
9. EU, Chapter 2.9.47, European Pharmacopeia (Apr. 2012).
10. PDA, Worskshop on Analytical Science and QBD, Mar. 6–7, 2012.
11. P. Nethercote et al., PharmaManufacturing 2010,
http://www.pharmamanufacturing.com/articles/2010/060.html, accessed Feb. 4, 2012.
12. USP, Medicines Compendia, General Chapter <10> (July 2011).
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14. E55.02 WK16888 A Risk Based Guidance for the Validation of PAT Methods – Draft
15. FDA, Guidance for Industry, Pharmaceutical Components at Risk for Melamine Contamination (Rockville, MD, August 2009).
16. FDA, Guidance for Industry, Heparin for Drug and Medical Device Use: Monitoring Crude, Heparin for Quality, Draft Guidance (Rockville, MD, February 2012).
17. 77 Federal Register 26162, pp. 26162 -26175.
18. Guideline on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for
new submissions and variations EMEA/CHMP/CVMP/QWP/17760/2009 Rev 2.
19. ASTM E2709–Standard Practice for demonstrating ability to comply with an acceptance procedure.