Developing a viable environmental monitoring program: For nonsterile pharmaceutical operations

Pharmaceutical Technology

Volumn 27, Issue 3, 2003, Pages 92-100

  Reich, Robert R ^a   Miller, Michael J ^a   Patterson, Hal ^a  

^a PSI   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENVIRONMENTAL ENGINEERING; MANUFACTURE; MONITORING;

ENVIRONMENTAL MONITORING PROGRAMS;

DRUG PRODUCTS;

CLINICAL PROTOCOL; DRUG MANUFACTURE; ENVIRONMENTAL MONITORING; PHARMACEUTICS; REVIEW; STANDARD;

EID: 0042320712     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (12)

1. FDA, Code of Federal Regulations, Title 21, Food and Drugs (handbook) Part 211.
2. General Test (1116), "Microbiological Evaluation of Cleanrooms and Other Controlled Environments," USP 24-NF 19 (US Pharmacopeial Convention, Rockville, MD, 2000), pp.2099-2106.
3. FDA, Center for Drug Evaluation and Research, "Guideline on Sterile Drug Products Produced by Aseptic Processing," Guidance Document, (June 1987).
4. PDA, Technical Report No. 13, "Fundamentals of a Microbiological Environmental Monitoring Program," (Parenteral Drug Association [PDA], Bethesda, MD, 2d ed., 2001).
5. M.L. Connor, AAI Benchmarking Survey, presented at the 7th Annual Pharmaceutical Microbiology Meeting, Wilmington, NC, April 1998.
6. R.L. Friedman, "Revision of the 1987 Aseptic Processing Guidance," paper presented at the 2002 PDA Annual Meeting, New Orleans, Louisiana, 10-12 December 2002.
7. J.D. Wilson, "Setting Alert-Action Limits for Environmental Monitoring Programs," PDA J. Pharm. Sci. Technol. 51 (4), 161-162 (1997).
8. F.E. Grubbs and G. Beck, "Extension of Sample Sizes and Percentage Points for Significance Tests of Outlying Observations," Technometrics TCMTA 14 (4), 847-854 (November 1972).
9. R.B. Dean and W.J. Dixon, "Simplified Statistics for Small Numbers of Observations," Anal. Chem. 23 (1), 636 (1951).
10. General Test <111>, "Design and Analysis of Biological Assays," USP 24-NF 19 (US Pharmacopeial Convention, Rockville, MD, 2000), pp. 1837-1847.
11. R.R. Reich, "Recovering Viable Particulates," MD & DI5 (20), 153-156 (May 1998).
12. PDA, Technical Report No. 13 (Revised), "Fundamentals of an Environmental Monitoring Program," (Parenteral Drug Association, Bethesda, MD, 2001).