Conclusion
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
http://www.ispe.org/.
References
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,
http://www.ispe.org/index.php/ci_id/33025/la_id/1.htm.
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).
14. EFPIA,
http://www.efpia.org/ (Publications/Science and Technical Affairs.)
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