A Single Adulteration Limit for Cleaning Validation in a Pharmaceutical Pilot-Plant Environment - Pharmaceutical Technology

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A Single Adulteration Limit for Cleaning Validation in a Pharmaceutical Pilot-Plant Environment


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7. R.J. Forsyth and D. Haynes, "Cleaning Validation in a Pharmaceutical Research Facility," Pharm. Technol. 22 (9), 104–112 (1998).

8. D.G. Dolan et al., "Application of the Threshold of Toxicological Concern Concept to Pharmaceutical Manufacturing Operations," Regul. Toxicol. Pharmacol. 43 (3), 1–9 (2005).

9. R. Baffi et al., "A Total Organic Carbon Analysis Method for Validating Cleaning Between Products in Biopharmaceutical Manufacturing," J. Parenter. Sci. Technol. 45 (1), 13–19 (1991).

10. R.J. Romanach et al., "Combining Efforts to Clean Equipment in Active Pharmaceutical Ingredient Facilities," Pharm. Technol. 23 (1), 46–58 (1999).

11. M.A. Stege et al., "Total Organic Carbon Analysis of Swab Samples for the Cleaning Validation of Bioprocess Fermentation Equipment," BioPharm 9 (4), 42–45 (1996).

12. D.A. LeBlanc, "Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of Finished Drug Products," Pharm. Technol. 22 (10), 136–148 (1998).

13. FDA, CDER Human Drug CGMP Notes, 6 (2), 5–6 (Rockville, MD, Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, 1998).

14. R.J. Forsyth, V. Van Nostrand, and G. Martin, "Visible Residue Limit for Cleaning Validation and its Potential Application in a Pharmaceutical Research Facility," Pharm. Technol. 28 (10), 58–72 (2004).

15. R.J. Forsyth and V. Van Nostrand, "Application of Visible Residue Limit for Cleaning Validation in a Pharmaceutical Manufacturing Facility," Pharm. Technol. 29 (10), 152–161 (2005).

16. R.J. Forsyth and V. Van Nostrand, "Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility," Pharm. Technol. 29 (4), 134–140 (2005).

17. R.J. Forsyth, J. Hartman, and V. Van Nostrand, "Risk-Management Assessment of Visible-Residue Limits in Cleaning Validation," Pharm. Technol. 30 (9), 104–114 (2006).


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