Validation and process capability

Pharmaceutical Technology

Volumn 22, Issue 6, 1998, Pages 66-76

  Kieffer, Robert ^a   Torbeck, Lynn ^b  

^a RGK Consulting   (United States)

^b Torbeck Associates   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIASTHMATIC AGENT;

FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; REVIEW; STATISTICAL ANALYSIS; TABLET MANUFACTURE; VALIDATION PROCESS; WEIGHT;

EID: 0031838206     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (16)

1. FDA, "Guidelines on General Principles of Process Validation," May 1987.
2. J. Nally and R. Kieffer, "The Future of Validation: From QC/QA to TQ," Pharm. Technol. 17(10), 106-116 (1993).
3. R. Kieffer, "Validation, Risk-Benefit Analysis," PDA J. Pharm. Sci. Technol. 49 (5), 249-252 (Sept./Oct. 1995).
4. USP 23/NF 18 〈1225〉 "Validation of Compendial Methods," pp. 1982-1984 (1995).
5. ICH, "Guideline on Validation of Analytical Procedures: Definitions and Terminology," Federal Register 60 (40), 11260-11262 (1 March 1995).
6. ICH, "Guideline on Validation of Analytical Procedures: Methodology," Federal Register 62 (96), 27464, 27467 (19 May 1997).
7. M.G. Natrella, Experimental Statistics (Handbook 91, US Government Printing Office, Washington, DC, 1963).
8. Minitab Release 10 for Windows (Minitab, Inc., State College, PA).
9. L. Nelson, "Nomograph of Sample Size for Estimating Standard Deviation," J. Qual. Technol. 8 (3), 179-180 (1976).
10. G.C. Davis et al., "Rational Approaches to Specification Setting: An Opportunity for Harmonization," Pharm. Technol. 20 (9), 110-118 (1996).
11. G.J. Hahn and W.Q. Meeker, Statistical Intervals, A Guide for Practitioners (John Wiley, New York, 1991).
12. T.R. Nichols and S. Dummer, "Assessing Pass/Fail Testing When There Are No Failures to Assess," Med. Device & Diagnostic Industry, pp. 97-99 (June 1997).
13. R. Kushler and P. Hurley, "Confidence Bounds for Capability Indices," J. Qual. Technol. 24 (4), 188, 195 (1992).
14. Joseph D. Nally, senior vice-president, R&D and Quality, Mutual Pharmaceutical Company Inc. United Research Laboratories, 1100 Orthodox Street, Philadelphia, PA; personal communication and validation data.
15. J. Bergum, "Constructing Acceptance Limits for Multiple Stage Tests," Drug Dev. Ind. Pharm. 16 (14) 2153-2166 (1990).
16. PDA, "Blend Uniformity Analysis: Validation and In-Process Testing," Technical Report No. 25, November 1997.