Specification Setting: Setting Acceptance Criteria from Statistics of the Data - - BioPharm International

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Specification Setting: Setting Acceptance Criteria from Statistics of the Data


BioPharm International
Volume 19, Issue 11

The cumulative percentage for a value of x is given by (1 – e-λx) and so the value of x corresponding to a required cumulative percentage (P) is x = –ln(1 – P) / λ. Thus, a 99.9% upper limit could be calculated by 6.91 / λ. If λ is estimated by the mean of the measurements, this is 6.91 times the mean.

More information about the Poisson and Exponential distributions can be found in the NIST/SEMATECH e-Handbook of Statistical Methods.3 Information about Solver, POISSON, and EXPONDIST is provided in Excel's Help option. Minitab provides the option to add an exponential distribution plot to a histogram.

REFERENCES

1. US Food and Drug Administration. International Conference on Harmonization; Guidance on specifications: Test procedures and acceptance criteria for biotechnological/biological products. Federal Register; 1999 Aug 19 [cited 2006 October 13];6(159):44934. Available from: http://www.fda.gov/cber/gdlns/ichtest.pdf

2. Deming WE. Some theory of sampling. NY: Dover Publications; 1966.

3. NIST/SEMATECH e-handbook of statistical methods. 2003 June 1 (updated 2006 July 18) [cited 2006 October 13]. Available from: http://www.itl.nist.gov/div898/handbook.

4. Howe WG. Two-sided tolerance limits for normal populations-some improvements. J of Am Statistical Assoc 1969;64:610-20.

5. Natrella MG. National Bureau of Standards handbook 91: Experimental statistics. Washington, DC: US Department of Commerce; 1963.

Excel procedures to apply all these methods can be obtained from

Terry Orchard is a statistician at Bespak Europe, Blackhill Dr., Featherstone Road, Wolverton Mill South, Milton Keynes, Buckinghamshire, MK12 5TS, England, + 44 (0)1908.552600, fax +44(0)1908.552613,


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