Identification of Factors Decreasing the Homogeneity of Blend and Tablet Uniformity

Pharmaceutical Technology

Volumn 28, Issue 3, 2004, Pages 110-122

  Garcia, Thomas P ^a   Carella, Anthony ^b   Pansa, Vincent ^a  

^a PFIZER INC   (United States)

^b Nonclinical Statistics Group   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

STATISTICAL METRICS; VARIANCE COMPONENT ANALYSIS;

DRUG PRODUCTS; POLYMER BLENDS; PRODUCT DEVELOPMENT; STATISTICAL METHODS;

DRUG PRODUCTS PLANTS;

DRUG INDUSTRY; GOOD MANUFACTURING PRACTICE; MONITORING; NEAR INFRARED SPECTROSCOPY; PROBABILITY; PROCESS TECHNOLOGY; QUALITY CONTROL; REVIEW; SAMPLING; STATISTICAL ANALYSIS; TABLET MANUFACTURE;

EID: 1542327708     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (9)

1. Boehm et al., "The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends," PDA J. Pharm. Sci. Technol. 57 (2), 64 (March-April 2003).
2. "Process Analytical Technology," presented at the FDA Pharmaceutical Science Advisory Committee, 23 October 2002, Rockville, Maryland.
3. AAPS 38th Annual Pharmaceutical Technologies Conference at Arden House, "The Key for Achieving New Standards of Development and Manufacturing Excellence and Regulatory Compliance: Process Analytical Technology," 26-31 January 2003, Harriman, New York.
4. J. Prescott and T. Garcia, "A Solid Dosage and Blend Content Uniformity Troubleshooting Diagram," Pharm. Technol. 25 (3), 68-88 (2001).
5. G.J. Hahn and W.Q. Meeker, Statistical Intervals: A Guide for Practitioners (John Wiley, New York, NY, 1991).
6. D.C. Montgomery, Introduction to Statistical Quality Control (Wiley, New York, NY, 1994).
7. S. Kotz and N.L. Johnson, Process Capability Indices (Chapman & Hall, New York, NY, 1993).
8. R. Kieffer and L. Torbeck, "Validation and Process Capability, " Pharm. Technol. 22 (6), 66-76 (1998).
9. PDA Technical Report No. 25, "Blend Uniformity Analysis: Validation and In-Process Testing," November 1997.