Biomedical Engineering Reference
In-Depth Information
should be immediately available at the workplace,
and on the other hand, that work should be performed
only according to approved and current SOPs.
13. The actual content of the SOPs will probably be better
addressed in later training at the departmental or unit
level.
14. 21 CFR Part 1301.73(b), “Security Requirements.”
15. 29 CFR ∫1910.38(c), “Emergency Action Plans.”
16. See Anthony Arthur (2006); see also Upton Sinclair
(1962).
17. See Arlene F. Kantor (1976); see also James H. Young
(1990). As Daniel Carpenter and Gisela Sin (2007) have
aptly put it, Sinclair's book “eased the path for the Pure
Food and Drugs Act of 1906.” Scott Sutton points out
that the
United States Pharmacopeia
(USP) was “recast
from its traditional focus of how to make medicines to the
role it would eventually take as a topic that describes the
safe making of medicines,” in its eighth revision, in 1900.
This provides further evidence that the regulatory climate
was ready for the passage of the Act. See Sutton (2009).
18. See Paul M. Wax (1995). DEG is used as an antifreeze.
See also Kirstin Jarrell (2012).
19. Quoted in Carpenter and Sin (2007), p. 168.
20. As Carpenter and Sin, op. cit. p. 177 have put it:
Had the sulfanilamide tragedy occurred at another
time, when FDA regulation as the dominant
alternative to the
status quo
was not advanced by
bureaucratic leaders, the Act would either not have
passed or would have taken a much different form.
Thus the tragedy was perhaps a necessary condition,
but hardly suffi cient, for the passage of the act.
