System performance and variability of chromatographic techniques used in pharmaceutical quality control

Journal of Chromatography B: Biomedical Sciences and Applications

Volumn 745, Issue 1, 2000, Pages 167-176

  Renger, Bernd ^a  

^a Byk Gulden ^*  (Germany)

Author keywords

Pharmaceutical quality control; System performance

Indexed keywords

CAPILLARY ELECTROPHORESIS; CONFERENCE PAPER; DRUG INDUSTRY; DRUG QUALITY; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INSTRUMENT; MATERIALS; PRIORITY JOURNAL; QUALITY CONTROL; ROBOTICS; TECHNIQUE; THIN LAYER CHROMATOGRAPHY;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS;

EID: 0034604792     PISSN: 13872273     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-4347(00)00211-5     Document Type: Conference Paper

References (45)

1. Grizodoub A.I., Levin M.G., Leontiev D.A., Georgievsky V.P. Pharmacom. 7:1995;8-19.
2. Pharmacopeial Forum. 24:1998;6366-6378.
3. Nilsson B., Törnblom J.-F., Karlén B., Spross B. Pharm. Ind. 48:1986;383-387.
4. US Pharmacopeia XXIV; <621> Chromatography, 1914-1926. 1999;US Pharmacopeial Convention, Rockville, MD.
5. Kristensen E., Varney M. Pharmacopeial Forum. 23:1997;4952-4957.
6. Draft Guidance for Industry: Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production. 1998;US Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD.
7. Quality Control Reports: The Gold Sheet. Vol. 27:1999;7-12 F-D-C-Reports, Chevy Chase, MD.
8. Schmidt R. Pharm. Ind. 60:1998;996-1001.
9. Pharm. Ind. 61:1999;1053-1055.
10. Bunnell R.D. Pharm. Technol. 21:1997;139-144.
11. Guide to the Expression of Uncertainty in Measurement. 1993;ISO, Geneva.
12. Quantifying Uncertainty in Analytical Measurement. 1995;Laboratory of the Government Chemist, London.
13. Dolan J.W. LC·GC Int. 11:1998;702-706.
14. Küppers S., Renger B., Meyer V. LC·GC Eur. 13:2000;114-118.
15. Furman W.B., Layloff T.P., Tetzlaff R.F. J. AOAC Int. 77:1994;1314-1317.
16. Bedson P., Sorgent M. Accred. Qual. Assur. 1:1996;265-274.
17. Bedson P., Rudd D. Accred. Qual. Assur. 4:1999;50-62.
18. Küppers S. GIT Labor Fachzeitsch. 3:1999;257-261.
19. CPMP/ICH/5626/94, Validation of Analytical Procedures: Definition and Terminology, International Conference on Harmonisation of Technical Requirements for Registration of Pharmceuticals for Human Use, Geneva, 1994 (FDA-Fed. Reg. 60 (1995) 11 260, available from http://www.ifpma.org/ich5q.html).
20. CPMP/ICH/281/95, Validation of Analytical Procedures: Methodology, International Conference on Harmonisation of Technical Requirements for Registration of Pharmceuticals for Human Use, Geneva, 1997 (FDA-Fed. Reg. 62 (1997) 27 463, available from http://www.ifpma.org/ich5q.html).
21. US Pharmacopoeia XXIV, <1225> Validation of Compendial Methods. 1999;2149-2152 US Pharmacopeial Convention, Rockville, MD.
22. Horwitz W., Albert R. Analyst. 122:1997;615-617.
23. S. Küppers, Schering AG, Berlin, private communication.
24. M. Zeller, Solvias AG, Basle, private communication.
25. Albert R., Horwitz W. Inside Lab. Manage. 1:1997;5-6.
26. J.C. Miller, J.N. Miller, Statistics for Analytical Chemistry, Horwood, New York, 1993.
27. The United States Pharmacopeia Commission, Draft Monograph <1010> Analytical Data - Interpretation and Treatment, Pharmacopeial Forum, 25 (1999) 8900-8909.
28. The United States Pharmacopeia Commission, Draft Monograph <1010> Analytical Data - Interpretation and Treatment, Pharmacopeial Forum, 24 (1998) 7051-7056.
29. Bunnell R.D. Pharm. Res. 14:1997;156-163.
30. J. Ermer, Aventis AG, Frankfurt, private communication.
31. King B. Accred. Qual. Assur. 4:1999;27-30.
32. Renger B. Pharm. Technol. Eur. 9:1997;36-44.
33. Neidhardt B., Mummenhoff W., Schmolke A., Beaven P. Accred. Qual. Assur. 3:1998;44-50.
34. Dudd D.R. J. Validation Technol. 5:1999;255-261.
35. Bar R. Accred. Qual. Assur. 4:1999;235-239.
36. R. Staal, Aventis AG, Frankfurt, private communication.
37. Measurement Systems Analysis, Reference Manual. 2nd ed. 1995;Chrysler Corporation, Ford Motor Company, General Motors Corporation.
38. Stafford J. Drug Dev. Ind. Pharm. 25:1999;1083-1091.
39. Daas A.G.J., Miller J.H.Mc.B. Pharmeuropa. 11:1999;571-577.
40. DeBeer J., DeSpiegeleer B., Hoogmartens J., Samson J., Massart D., Moors M. Analyst. 117:1992;933-940.
41. Daas A.G.J., Miller J.H.Mc.B. Pharmeuropa. 9:1997;148-156.
42. Daas A.G.J., Miller J.H.Mc.B. Pharmeuropa. 10:1998;137-146.
43. Vaart F.J.V.D. Pharmeuropa. 9:1997;139-143.
44. Ebel S. Pharmeuropa. 9:1997;143-147.
45. ICH Harmonized Tripartite Guideline Q6A-Draft, Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. 1999;ICH, Geneva.