Biomedical Engineering Reference
In-Depth Information
manufacturing and testing of fi nished product are not
calibrated on a routine basis.” Available from: www.
fda.gov/foi/warning_letters/archive/g1833d.pdf
27. Available
from:
www.fda.gov/foi/warning_letters/
archive/b6289d .pdf
28. Available
from:
www.fda.gov/foi/warning_letters/
archive/g3695d.pdf
29. Available
from:
www.fda.gov/foi/warning_letters/
archive/ g 5817d.pdf
30. Available
from:
www.fda.gov/foi/warning_letters/
archive/g5014d.pdf
31. See Gamal Amer (2008).
3.7 References
Amer, G. (2008) Corrective action preventive action (CAPA):
a risk mitigating quality system. Pharma. Eng. 28(3), 67
and 72.
Claycamp, H.G. (2006) ICH Q9: Quality risk management.
Presentation to the CDER Advisory Committee for
Pharmaceutical Science (ACPS ), Rockville, MD, CDER, 5
October 2006.
FDA (1987) Guideline on General Principles of Process
Validation , Rockville, MD, CDER, May 1987, p. 4.
FDA (2006) Managing Food Safety , College Park, MD:
Center for Food Safety and Applied Nutrition, April 2006,
p. 58.
Ferrier, M. (2006) Risk-based validation of computer
systems, Presentation to the NJ Chapter, ISPE, 15 June.
Fetterolf, D. (2007) Developing a sound process validation
strategy. BioPharm. Internat . 20(12), 44-5.
Garcia, T. et al. (2008) PQLI Key topics - criticality, design
space, and control strategy. J. Pharma. Innov . 3(2), 60-8.
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