Regulatory Challenges in the QbD Paradigm - The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical

ADVERTISEMENT

Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.


BioPharm International
Volume 25, Issue 9, pp. 44-53

ACKNOWLEDGMENTS

The authors would like to thank Patricia Hughes and Kalavati Suvarna, both from FDA, for helpful discussions regarding this article.

ANASTASIA G. LOLAS (not pictured) is president of Visionary Pharma Consulting, Olney, MD, and ANURAG S. RATHORE, PHD*, is a consultant at Biotech CMC Issues and a member of the faculty in the department of chemical engineering at the Indian Institute of Technology. Rathore is also a member of BioPharm International's Editorial Advisory Board.

*To whom correspondence should be addressed,
.

REFERENCES

1. J. Arrowsmith, Nature Biotechnol. 11, 17–18 (2012).

2. FDA, Notice of Pilot Program for Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products, Docket number FDA-2008-N-03551.

3. FDA, Pharmaceutical CGMPs for the 21st Century - A Risk-Based Approach, Final Report (Rockville, MD, Sept. 2004).

4. J.M. Juran, Juran on Quality by Design, (The Free Press, 1992).

5. ICH Q8(R1) Pharmaceutical Development (2008).

6. FDA, Guidance for Industry, PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance (Rockville, MD, Sept. 2004).

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

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

9. FDA, Guidance for Industry, Process Validation: General Principles and Practices (Rockville, MD, 2011).

10. A.S. Rathore and H. Winkle, Nature Biotechnol. 27, 26–34 (2009).

11. A.S. Rathore Trends in Biotechnol. 27, 546–553 (2009).

12. S. Kozlowski and P. Swann (2009) "Considerations for Biotechnology Product Quality by Design," In: A.S. Rathore and R. Mhatre (eds) Quality by Design for biopharmaceuticals: Perspectives and Case Studies, (Wiley Inter-science, New Jersey, 2009), pp. 9–30.

13. FDA, "Drug and Biological Product Consolidation," Fed. Regist. 68 (123), June 2003.

14. FDA, Center for Drug Evaluation and Research Manual of Policies and Procedures, MAPP 4730.3, Office of Biotechnology Products and Office of ComplianceDivision of Manufacturing & Product Quality Interactions on BLA Assessments, http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM195932.pdf.

15. FDA, Inspections of Licensed Biological Therapeutic Drug Products, Compliance Program Guidance Manual, Program 7356.002M, 2006, http://www.fda.gov/downloads/ICECI/ComplianceManuals/ComplianceProgramManual/ucm125422.pdf

16. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC), Part 601.12.

17. FDA, Guidance for Industry, Guidance for Industry: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Rockville, MD, July 1997).

18. ICH, Q5E Comparability of Biotechnological/ Biological Products Subject to Changes in Their Manufacturing Process (2003).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

First Biosimilar Application Kicks Off Legal Battle
October 31, 2014
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Author Guidelines
Source: BioPharm International,
Click here