In response to ICH and regulatory guidelines, a group of experts representing the industry who have successfully prosecuted
enhanced, QbD approaches to development and manufacture of drug substances and drug products have produced for ISPE two parts
of a guide series on product realization. These guides can serve as learning material for practitioners and be a reference
of relevant information.
Bruce S. Davis is a principal, Global Consulting; Ranjit R. Deshmukh, PhD, is senior director of Corporate Technical Science, MedImmune; John V. Lepore, PhD, is senior director, Chemical Process Development and Commercialization, Merck & Co Inc.; Line Lundsberg-Nielsen, PhD, is a senior consultant, NNE Pharmaplan; Roger Nosal is vice-president, Global Chemistry, Manufacturing & Controls, Pfizer, Inc.; Stephen M. Tyler is director, Analytics and Technical Projects, Abbott Laboratories; and Christopher Potter, PhD*, is a CMC Pharmaceutical Consultant.
*To whom all correspondence should be addressed.
Note: The ISPE Guide series is available at
1. ICH, Q8(R2) Pharmaceutical Development (August 2009).
2. ICH, Q9 Quality Risk Management (November 2005).
3. ICH, Q10 Pharmaceutical Quality System (June 2008).
4. FDA, Guidance for Industry: Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach (September 2004).
5. FDA, Guidance for Industry: PAT–A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (September 2004).
6. FDA, Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations (September 2006).
7. FDA, Guidance for Industry: Process Validation: General Principles and Practices (January 2011).
8. ICH, Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), Step 2 (May 2011).
9. ICH, Q8, Q9, and Q10 Questions and Answers, Rev. 4 (November 2011).
10. ICH Quality Implementation Working Group, Points to Consider, ICH-Endorsed Guide for ICH Q8, Q9, and Q10 Implementation, Rev. 2 (December 2011).
11. ISPE Guide Series, Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement,
12. J. Lepore and R. Nosal, R. "Industry Perspective: Value Proposition for Applications of Risk-Based Approaches," presented
at ISPE Brussels Conference (2011).
13. C.J. Potter, Jrnl. of Pharma. Innov. 1:4–23 (2009).
http://www.efpia.org/ (Publications/Science and Technical Affairs.)