Biomedical Engineering Reference
In-Depth Information
3.6 Notes
1. According to the FDA, “Standard Operating Procedure
(SOP) means a written method of controlling a practice
in accordance with predetermined specifi cations to
obtain a desired outcome.” See, for instance, FDA
(2006).
2. These changes usually do not include the correction of
typographical errors, the addition of clarifying
statements, the updating of organizational names, etc.
to currently implemented procedures. Since an SOP is a
life-cycle document, such “cosmetic” changes could
well wait until the next regularly scheduled procedure
review.
3. See FDA (1987).
4. The ISO standard 9000:2000 defi nes “validation” as
“confi rmation through the provision of objective
evidence that the requirements for a specifi c intended
use or application have been fulfi lled . . .” See ISO 9000
(2000).
5. See William R. Shadish, Thomas Cook, and Donald
Campbell (2002); see also James H. McMillan (2007).
6. On the Rosenthal effect, see Robert Rosenthal (1966);
also see Rosenthal (1998).
7. See William R. Shadish, Thomas Cook, and Donald
Campbell (2002).
8. See, for instance, N.N. Radaev (2004).
9. As H. Gregg Claycamp (2006) has put it in his
presentation to the CDER Advisory Committee for
Pharmaceutical Science (ACPS), there are a number of
kinds of risk for a company - strategic risks, operational
risks, fi nancial risks, compliance risks, competitor
advantage, company viability, shareholder harm, patient
harm, etc. This chapter focuses on quality risks.
