The application of quality by design to analytical methods

Pharmaceutical Technology

Volumn 31, Issue 10, 2007, Pages 142-152

  Borman, Phil ^a   Chatfield, Marion ^a   Nethercote, Phil ^a   Thompson, Duncan ^a   Truman, Keith ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY AND PRECISION; ANALYTICAL METHODOLOGY; ANALYTICAL METHODS; MONITOR AND CONTROL; TARGET ANALYTES;

ANALYTIC METHOD; CONTROL STRATEGY; EVALUATION; METHODOLOGY; PROCESS CONTROL; QUALITY CONTROL; REVIEW;

EID: 53649095609     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (18)

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.