Evaluation of blend sampling errors: A statistical approach

Pharmaceutical Technology

Volumn 23, Issue 6, 1999, Pages 56-66

  Hwang, Ruey Ching ^a,b   Huang, Ye ^a   Peck, Gretchen R ^a  

^a MALLINCKRODT PHARMACEUTICALS   (United States)

^b Editorial Advisory Board ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG APPROVAL; DRUG CAPSULE; DRUG MANUFACTURE; GOOD MANUFACTURING PRACTICE; REVIEW; SAMPLING; TABLET FORMULATION;

EID: 0033010179     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (15)

1. FDA, "Guide to Inspections of Oral Solid Dosage Forms Pre/Post-Approval Issues for Development and Validation," January 1994.
2. US v. Barr Laboratories, Cons. Docket 92-1744 (AMW), Court Ruling, 4 February 1993.
3. FDA, "Current Good Manufacturing Practice: Amendment of Certain Requirements for Finished Pharmaceuticals; Proposed Rule," 3 May 1996 (61 FR 20103).
4. C.F. Harwood and K.A. Walanski, "Monitoring the Mixing of Powders," Org. Coat. Plast. Chem. 33 (2), T305-T315 (1964).
5. C. Schofield, "The Definition and Assessment of Mixture Quality in Mixtures of Particulate Solids," Powder Technol. 5, 169-180 (1976).
6. C.F. Harwood and T. Ripley, "Errors Associated with the Thief Probe for Bulk Powder Sampling," J. Powder Bulk Solids Technol. 1, 20-29 (1977).
7. J.T. Carstenson and C.T. Rhodes, "Sampling in Blending Validation," Drug Dev. Ind. Pharm. 19 (20), 2699-2708 (1993).
8. J. Berman, A. Schoeneman, and J.T. Shelton, "Unit Dose Sampling - A Tale of Two Thieves," Drug Dev. Ind. Pharm. 22 (11), 1121-1132 (1996).
9. S. Bolton et al., "Is It Necessary to Take Small Blend Samples to Assess Drug Uniformity?" Pharm. Dev. Technol. 2 (3), 297-299 (1997).
10. PDA Technical Report, "Blending Uniformity Analysis: Validation and In-Process Testing," draft, 30 April 1997.
11. S. Mohan et al., "Unit-Dose Sampling and Blend Content Uniformity Testing," Pharm. Technol. 21 (4), 116-125 (1997).
12. J.M. Dietrich, "Food and Drug Administration Recommendations on Validation Issues," Regul. Affairs 5, 363-366 (1993).
13. P.J. Motise, W. Crabbs, and T. Lord, "Solid Oral Dosage Forms: Blend Uniformity Acceptance Criteria," Human Drug CGMP Notes (May 1993), pp. 5-6.
14. Chapter 〈905〉, "Uniformity of Dosage Units," USP 23/NF 18 (US Pharmacopeial Convention, Rockville, MD, 1995).
15. T. Garcia, B. Elsheimer, and F. Tarczynski, "Examination of Components of Variance for a Product Scale, Low-Dose Powder Blend and Resulting Tablets," Drug Dev. Ind. Pharm. 21 (18), 2035-2045 (1995).