Quality by Design for Analytical Methods: Implications for Method Validation and Transfer - Pharmaceutical Technology

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PharmTech Europe

Quality by Design for Analytical Methods: Implications for Method Validation and Transfer
The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.

Pharmaceutical Technology
Volume 36, Issue 10, pp. 74-79


1. P. Nethercote, et al., "QbD for Better Method Validation and Transfer," Pharmamanuf. online, http://www.pharmamanufacturing.com/articles/2010/060.html, accessed June 10, 2012.

2. FDA, Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach (Rockville, MD, 2004).

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

4. M. Nasr, presentation at the AAPS Workshop (North Bethesda, MD, Oct. 5, 2005).

5. ICH, Q2(R1), Validation of Analytical Procedures: Text and Methodology, Step 4 version (2005).

6. P. Borman, et al., Pharm. Tech., 31 (10), 142–152 (2007).

7. USP General Chapter <1058>, "Analytical Instrument Qualification."

8. J. Ermer and J.S. Landy, "Validation of analytical procedures," in Encyclopedia of Pharmaceutical Technology, J. Swarbrick and J.C. Boylan, Eds. (Dekker, New York, 2nd ed., 2002), pp. 507–528.

9. ICH, Q8, Pharmaceutical Development (2009).

10. M. Schweitzer, et al., Pharm. Tech., 34(2), 52–59 (2010).

11. P.J. Borman, et al., Anal. Chim. Acta., 703(2), 101–113 (2011).

12. J. Ermer, et al., J. Pharm. Biomed. Anal., 38(4) 653–663 (2005).

13. USP General Chapter <1010>, "Analytical Data Interpretation & Treatment."

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

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

16. E. Ciurczak, "ICH Guidances (Already) Show Their Age," http://www.pharmamanufacturing.com/articles/2008/158.html, accessed June 10, 2012.


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