Acceptance Limits for the New ICH USP 29 Content-Uniformity Test - Pharmaceutical Technology

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Acceptance Limits for the New ICH USP 29 Content-Uniformity Test
Revisions to the United States Pharmacopeia's (USP) uniformity test require manufacturers to establish new acceptance limits. The authors present their method for calculating acceptance limits consistent with USP's revised content-uniformity test requirements.


Pharmaceutical Technology


References

1. United States Pharmacopeia, "‹905› Uniformity of Dosage Units," Pharmacopeial Forum 32 (6), 1653–1659, 2006.

2. Statistics Working Group of PhRMA, "Content Uniformity: Evaluation of the USP Pharmacopeial Preview," Pharmacopeial Forum 24 (5), 7029–7044, 1998.

3. Statistics Working Group of PhRMA, "Content Uniformity: Alternative to the USP Pharmacopeial Preview," Pharmacopeial Forum 25 (2), 7939–7948, 1999.

4. Statistics Working Group of PhRMA, "Recommendations for a Globally Harmonized Uniformity of Dosage Units Test," Pharmacopeial Forum , 25 (4), 8609–8624, 1999.

5. J.S. Bergum, "Constructing Acceptance Limits for Multiple Stage Tests," Drug Dev. Ind. Pharm. 16 (14), 2153–2166, 1990.

6. J.S. Bergum and M.L. Utter, "Process Validation," in Encyclopedia of Biopharmaceutical Statistics, S.C. Chow, Ed., (Marcel Dekker, New York, 2000), pp. 422–439.

7. J.S. Bergum and M.L. Utter, "Statistical Methods for Uniformity and Dissolution Testing" in Pharmaceutical Process Validation, Robert A. Nash and Alfred H. Watchter, Eds., (Marcel Dekker, New York, 2003), pp. 667–697.

8. J. S. Bergum's SAS Programs, Content Uniformity and Dissolution Acceptance Limits (CUDAL), version: 1.0, validation completed 02/11/02.

9. J.B. Berman et al., "Blend Uniformity Analysis: Validation and in-process testing," Technical Report No. 25, PDA J. Pharm. Sci. Technol. (suppl.) 51, 1997.

10. B.W. Lindgren, "Normal Populations" in Statistical Theory, C. B. Allendoerfer, (Macmillan, New York,1968), 390–391.

11. F.A. Graybill and C.M. Wang, "Confidence Intervals on Nonnegative Linear Combination of Variances," J. Am. Stat. Assoc. 75 (372), 869–873, 1980.


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