Blend uniformity analysis: Validation and in-process testing

PDA Journal of Pharmaceutical Science and Technology

Volumn 51, Issue 3 SUPPL., 1997, Pages

  Berman, J ^a   Elinski, D E ^a   Gonzales, C R ^a   Hofer, J D ^a   Jimenez, P J ^a   Planchard, J A ^a   Tlachac, R J ^a   Vogel, P F ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; MEDICAL TECHNOLOGY; QUALITY CONTROL; REVIEW; SAMPLING; STANDARD;

EID: 0031413466     PISSN: 1076397X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (11)

1. "Guideline on General Principles of Process Validation," May, 1987, Division of Manufacturing and Product Quality, Office of Compliance, Center for Drugs and Biologics, PDA, 5600 Fishers Lane, Rockville, MD 20857.
2. J.S. Bergum, "Constructing Acceptance Limits for Multiple Stage Tests," Drug Development and Industrial Pharmacy, 16, 2153-2166, (1990).
3. G.J. Hahn, and W.Q. Meeker, Statistical Intervals: A Guide for Practitioners, John Wiley & Sons, Inc., New York, 1991, pp. 34-36, 58-61.
4. J. Guentensberger, P. Lameiro, A. Nyhuis, B. O'Connell, S. Tigner, "A Statistical Approach to Blend Uniformity Acceptance Criteria," to appear in Drug Development and Industrial Pharmacy.
5. G.J. Hahn, and W.Q. Meeker, op.cit., pp. 31-34, 64.
6. J. Berman and J.A. Planchard "Blend Uniformity and Unit Dose Sampling," Drug Development & Industrial Pharmacy, V. 21, Issue 11, pp. 1257-1283, (1995).
7. J. Dietrick, presented at a "Special Forum on Blend Analysis," sponsored by PDA, Rockville, MD, January, 1996.
8. T. Garcia, B. Elsheimer and F. Tarczynski "Examination of Components of Variance for a Production Scale, Low Dose powder Blend and Resulting Tablets," Drug Development & Industrial Pharmacy, V. 21, Issue 18, pp. 2035-2045, (1995).
9. D.C. Montgomery, Design and Analysis of Experiments, 3rd Ed., John Wiley and Sons, pp. 81-87, (1991).
10. J. Berman, A. Schoeneman and J.T. Shelton, "Unit Dose Sampling - A Tale of Two Thieves," accepted by Drug Development & Industrial Pharmacy, Vol. 22, Issue 11, pp. 1121-1132, (1996).
11. G.W. Snedecor and W.G. Cochran, Statistical Methods, 8th Ed., Iowa State University Press, Ames, IO, p.97.