Establishing scientifically justified acceptance criteria for cleaning validation of finished drug products

Pharmaceutical Technology

Volumn 22, Issue 10, 1998, Pages

  LeBlanc, Destin A ^a  

^a STERIS Corporation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ARTICLE; CLEANING; DRUG CONTAMINATION; DRUG MANUFACTURE; DRUG STERILITY; EQUIPMENT; MICROBIOLOGICAL EXAMINATION;

EID: 7844220598     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. FDA, "Guide to Inspections of Validation of Cleaning Processes," Division of Investigations, Office of Regional Operations, Office of Regulatory Affairs, July 1993.
2. G.L. Fourman and M.V. Mullen, "Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations," Pharm. Technol. 17 (4), 54-60 (1993).
3. K.M. Vitale, "Cleaning Validation Acceptance Criteria," presented at the 15th Annual Pharm Tech Conference '95, East Brunswick, New Jersey, 18-21 September 1995.
4. R. Brewer, "Regulatory Aspects of Cleaning Validation," presented at ISPE seminar, Rockville, Maryland, 6-8 March 1996.
5. PDA Biotechnology Cleaning Validation Subcommittee, Cleaning and Cleaning Validation: A Biotechnology Perspective (PDA, Bethesda, MD, 1996).
6. W.A. Hall, "Cleaning for Bulk Pharmaceutical Chemicals (BPCs)," in Validation of Bulk Pharmaceutical Chemicals, D. Harpaz and I.R. Barry, Eds. (Interpharm Press, Buffalo Grove, IL, 1997), pp. 335-370.
7. D.A. LeBlanc, "Rinse Sampling for Cleaning Validation Studies," Pharm. Technol. 22 (5), 66-74 (1998).
8. R.B. Kirsch, "Validation of Analytical Methods Used in Pharmaceutical Cleaning Assessment and Validation," in 1998 Analytical Validation in the Pharmaceutical Industry, supplement to Pharm. Technol. 40-46 (1998).
9. K.M. Jenkins and A.J. Vanderweilen, "Cleaning Validation: An Overall Perspective," Pharm. Technol. 18 (4), 60-73 (1994).
10. R. Dabbah, "Microbial Evaluation of Cleanrooms and Other Controlled Environments - In-Process Revision," Pharm. Forum 23 (1), 3494-3520 (Jan.-Feb. 1997).