References
1. K.M. Jenkins and A.J. Vanderwielen, Pharm. Technol.,
18 (4), 60–73 (1994).
2. R. J. Forsyth and D. Haynes, Pharm. Technol.,
22 (9), 104– 112 (1998).
3. D. A. LeBlanc, D. D. Danforth, and J. M. Smith, Pharm. Technol.,
17 (10), 118–1124 (1993).
4. B. D. Naumann and P. A. Weideman, Human Ecol. Risk Assess.
1 (5), 590–613 (1995).
5. B. D. Naumann and E. V. Sargent, Occup. Med.
12 (1), 33–42 (1996).
6. G. L. Fourman and M. V. Mullen, Pharm. Technol.,
17 (4), 54–60 (1993).
7. R. J. Forsyth, A. LeBlanc, and M. Voaden, Pharm. Technol.,
31 (1), 74- 83 (2007).
8. FDA, "Guide to Inspection of Validation of Cleaning Processes" (Rockville, MD, July 1993).
9. Health Canada, "Cleaning Validation Guidelines" (June 2002).
10. PIC/S, Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-sterile Process Validation, Cleaning
Validation (PI 006-2, July 2004).
11. EudraLex, "Qualification and Validation" (Annex 15, July 2001).
12. M. Lazar, Pharm. Technol.,
21 (9), 56–73 (1997).
13. D. A. LeBlanc, PDA J. Pharm. Sci. and Technol.,
56 (1), 31–36 (2002).
14. J.M. Cardot and E. Beyssac, Cont. Environ.,
11 (6), 11–14 (2008).
15. R. J. Romanach et. al., Pharm. Technol.,
23 (1), 46–58 (1999).
16. M. C. Oliver, Eur. J. Parent. Sci., 5 (4), 97–100 (2000).
17. J. E. Martinez, Pharm. Technol.,
26 (11), 62–74 (2002).
18. R. J. Forsyth and V. Van Nostrand, Pharm. Technol.,
28 (10), 58–72 (2004).
19. R. J. Forsyth and V. Van Nostrand, Pharm. Technol.,
29 (10), 152– 161 (2005).
20. R.J. Forsyth et al., Pharm. Technol.,
30 (11), 90–100 (2006).
21. R.J. Forsyth, Pharm. Technol.,
33 (3), 102–111 (2009).
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