Using tolerance intervals for setting process validation acceptance criteria

BioPharm International

Volumn 20, Issue 6, 2007, Pages 40-46

  Burdick, Rick ^a   Gleason, Tom ^b   Rausch, Steve ^b   Seely, Jim ^b  

^a Quality Engineering and Improvement Department

^b Manufacturing Science and Technology Department

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT PROTEIN;

DATA ANALYSIS; DRUG INDUSTRY; DRUG MANUFACTURE; GOOD MANUFACTURING PRACTICE; PROBABILITY; PROCESS CONTROL; PROCESS TECHNOLOGY; PROCESS VALIDATION; REVIEW; STATISTICAL ANALYSIS; STATISTICAL MODEL;

EID: 34447266964     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (8)

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2. Kieffer R, Bureau S, Borgmann A. Applications of failure modes and effects analysis to the pharmaceutical industry. Pharm Tech Eur. 1997; Sept(9):36-49.
3. Stamatis DD. Failure modes and effects analysis; FMEA from theory to execution. 2nd ed. Milwaukee (WI):ASQ Quality Press; 2003.
4. Wald A, Wolfowitz J. Tolerance limits for a normal distribution. Ann of Math Stat 1946(17);208-15.
5. Howe WG. Two-sided tolerance limits for normal populations, some improvements. J Am Stat Assoc. 1969(64): 610-20.
6. Orchard T. Setting acceptance criteria from statistics of the data. BioPharm Int. 2006; Nov (19):22-9.
7. Hahn GJ, Meeker WQ. Statistical intervals: a guide to practitioners. New York (NY): Wiley; 1991.
8. Neter J, Kutner MH, Nachtsheim CJ, Wasserman, W. Applied linear statistical models. 4th ed. Scarborough, Ontario (Can): Irwin; 1996.