The Application of Quality by Design to Analytical Methods - Pharmaceutical Technology

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The Application of Quality by Design to Analytical Methods
To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs.

This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).



Pharmaceutical Technology


Phil Borman,* is a manager in Strategic Technologies, Chemical Development, at GlaxoSmithKline, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY UK, tel. 44 1438 763713, fax 44 1438 764414,
Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire). Phil Nethercote is a director in New Product Support, Global Manufacturing Supply at GlaxoSmithKline (Ayrshire, UK). Duncan Thompson is a senior process analyst in Strategic Technologies, Chemical Development at GlaxoSmithKline (Hertfordshire). Keith Truman is vice-president of the Scientific Information Centre of Excellence, Pharmaceutical Development, at GlaxoSmithKline (Hertfordshire).

*To whom all correspondence should be addressed.

Submitted: June 21, 2007. Accepted: Aug. 2, 2007.

References

1. US Food and Drug Administration, Pharmaceutical CGMPs for the 21st Century—A Risk Based Approach, 2004.

2. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline Q8 Pharmaceutical Development, 2006.

3. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline Q9 Quality Risk Management, 2006.

4. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Quality Guideline Q2(R1) Validation of Analytical Procedures: Text and Methodology, 2005)

5. USP 29–NF 24 (United States Pharmacopoeial Convention, 2006), Chapter ‹1225›.

6. M. Glodek et al., "Process Robustness —A PQRI White Paper," Pharm. Eng. 26 (6), 1–11 (Nov.–Dec. 2006).

7. FDA 21 CFR Title Parts 210– 226 (2006).

8. M. Nasr, "FDA Perspective on the Implementation of Quality by Design," paper presented at the Ninth APIC/CEFIC (Prague, Czech Republic, Oct. 2006).

9. M. Swartz and I. Krull, "Analytical Method Transfer," LC-GC 24 (11), 20–24, (2006).

10. ISPE Good Practice Guide: Technology Transfer (ISPE, Tampa, Florida, 2003).

11. S. Scypinski et al., "Analytical Method Transfer," Pharm. Technol. 26 (3), 84–88 (2002)

12. PhRMA Analytical Research and Development Workshop, Wilmington, Delaware, Sept. 20, 2000.

13. "The Metamorphosis of Manufacturing," IBM report, Apr. 2005.

14. D. Nevalainen et al., "Evaluating Laboratory Performance on Quality Indicators with the Six Sigma Scale," Arch. Pathol. Lab. Med. 124, 516–519 (2000).

15. K. Ishikawa, What is Total Quality Control? The Japanese Way (Prentice-Hall, Englewood Cliffs, NJ, 1985), 63–64.

16. D. Stamatis, Failure Modes and Effects Analysis, FMEA from Theory to Execution (ASQ Qualtiy Press, Milwaukee, WI, 2d ed., 2003).

17. R. McDermott, R. Mikulak, and M. Beauregard, The Basics of FMEA (Quality Resources, New York, 1996).

18. Dyadem Press, "Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices," 2003.


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