Using visible residue limits for: Introducing new compounds into a pharmaceutical research facility

Pharmaceutical Technology

Volumn 29, Issue 4, 2005, Pages 134-140

  Forsyth, Richard J ^a   Van Nostrand, Vincent ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLEANING; TOXICITY;

CLEANING VALIDATION; PHYSICAL HANDLING; VISIBLE RESIDUE LIMITS;

DRUG PRODUCTS PLANTS;

CLEANING; DRUG INDUSTRY; EQUIPMENT; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PHARMACEUTICS; REVIEW; SAFETY; SOLUBILITY; TECHNOLOGY; TOTAL ORGANIC CARBON; ULTRAVIOLET RADIATION; WASTE;

EID: 17644423442     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (17)

1. FDA, "Guide to Inspection of Validation of Cleaning Processes" (Division of Field 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. D.A. LeBlanc, D.D. Danforth, and J.M. Smith, "Cleaning Technology for Pharmaceutical Manufacturing," Pharm. Technol. 17 (10), 118-124 (1993).
4. K.M. Jenkins and A.J. Vanderwielen, "Cleaning Validation: An Overall Perspective," Pharm. Technol. 18 (4), 60-73 (1994).
5. H.L. Avallone, "Drug Substance Manufacturing and Control," Pharm. Eng. 9 (2), 37-57 (1989).
6. M. Montalvo and A. Hewing, "How to Develop an Effective and Successful Cleaning Validation Program," J. Val. Technol. 10 (1) 62-82 (2003).
7. D.W. Mendenhall, "Cleaning Validation," Drug Dev. Ind. Pharm. 15 (13), 2105-2114 (1989).
8. R.J. Forsyth and D. Haynes, "Cleaning Validation in a Pharmaceutical Research Facility," Pharm. Technol. 22 (9), 104-112 (1998).
9. PhRMA Quality Committee, "PhRMA Guidelines for the Validation of Cleaning Procedures for Bulk Pharmaceutical Chemicals," Pharm. Technol. 21 (9), 56-73 (1997).
10. A.O. Zeller, "Cleaning Validation and Residue Limits: A Contribution to Current Discussions," Pharm. Technol. 17 (10) 70-80 (1993).
11. W.K. Gavlik, L.A. Ohlmeier, and H.J. Kaiser, "Analytical Strategies for Cleaning Agent Residue Determination," Pharm. Technol. 19 (3), 136-144 (1995).
12. J.A. Shea et al., "Validation of Cleaning Procedures for Highly Potent Drugs. I. Losoxantrone," Pharm.Dev. Technol. 1 (1), 69-75 (1996).
13. R. Baffi et. al., "A Total Organic Carbon Analysis Method for Validating Cleaning Between Products in Biopharmaceutical Manufacturing," J. Paren. Sci. Technol. 45 (1), 13-19 (1991).
14. K.M. Jenkins et al., "Application of Total Organic Carbon Analysis to Cleaning Validation," PDA J. Pharm. Sci. Technol. 50 (1), 6-15 (1996).
15. R. Sharnez et al., "In Situ Monitoring of Soil Dissolution Dynamics: A Rapid and Simple Method for Determining Worst-case Soils for Cleaning Validation," PDA J. Pharm. Sci. Technol., 58 (4), 203-214 (2004).
16. R.J. Forsyth, V. Van Nostrand, and G. Martin, "Visible Residue Limit and its Application in a Pharmaceutical Research Facility," Pharm. Technol. 28 (10), 58-72 (2004).
17. D.A. LeBlanc, "'Visually Clean' as a Sole Acceptance Criteria for Cleaning Validation Protocols," PDA J. Pharm. Sci. Technol. 56 (1), 31-36 (2002).