» LARGE MOLECULE
»
References 1.
2.
Fowler M, Vanderhooft J, Subramanyan V. Realizing process analytical technology (PAT) in process development by implementation of near infrared (NIR) spectroscopy. Pharmaceutical Engineering. 2013;33(5):90-94.
International Conference on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline, Pharmaceutical Development –Q8(R2). August 2009. Available at:
www.ich.org. Accessed November 21, 2014.
3. Figure 4. SSL Topical Product: Predicted Optimal Container Filling Process Parameters.
International Conference on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline, Quality Risk Management– Q9. November 2005. Available at:
www.ich.org. Accessed November 21, 2014.
4.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline, Pharmaceutical Quality
Systems–Q10. June 5. 2008. Available at:
www.ich.org. Accessed November 21, 2014.
U.S. Food and Drug Administration. Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms. April 2012. Available at:
www.fda.gov. Accessed November 21, 2014.
6.
U.S. Food and Drug Administration. Quality by Design for ANDAs: An Example for Moderate Release Dosage Forms. December 2011.Available at:
www.fda.gov. Accessed November 21, 2014.
Figure 5. SSL Topical Product: Container Filling Design Space. 7.
U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER), Manual of Policies and Procedures MAPP 5016.1. Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review. February 2011. Available at:
www.fda.gov. Accessed November 21, 2014.
in development work is obvious. Planning and executing a single development phase DOE yielded information that enabled the identifi cation of CPPs and, whether factor interactions existed or not, predicted optimal CPP ranges in which to operate and generated a design space at commercial scale.
Conclusion
The generic pharmaceutical industry faces the practical challenge of balancing the level of QbD implementation with business objectives. Some sponsors avoid implementing QbD in early stages of development due to aggressive project timelines in the race to fi le fi rst, a lack of resources, a lack of management support, or a combination of all 3 factors. The QbD elements discussed in this paper have off ered
22 | | January/February 2015
several approaches to implementing QbD in the early development phase of generic topical product. Some elements presented in this discussion, such as identifying a QTPP and CQAs, are base requirements in ANDA submissions, while others are not, and require planning, resources and management support. Regardless of the level of implementation of QbD elements into early development work, planning with the entire development team—not only engineers and technical support, but also regulatory, quality, and laboratory support teams—is necessary to facilitate implementing new workfl ows in product and process development. With careful thought and planning, aspects initially considered to be resource-demanding can, in fact, not only be feasible, but decrease overall development time while increasing product and process understanding.
Author Biography
Michael Fowler is a Principal Process Engineer in the Transdermal Development division of Actavis located in Salt Lake City, Utah. He is responsible for research and development, scale-up, and technology transfer activities of branded and generic semi-solid and liquid transdermal products. Michael is a core team member tasked to implement Quality by Design in the development of semi-solid and liquid products at Actavis in Salt Lake City. He has over 10 years of experience in formulation and process development in Transdermal and Topical drug delivery technologies. Michael graduated from the University of Utah with a Bachelor’s Degree in Materials Science and Engineering and Master’s Degree of Business and Administration in product development.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76