Biomedical Engineering Reference
In-Depth Information
Figure 4.7
Continued
4.4 Conclusion
This chapter presented a template for the development of
SOPs, including the relation of a process map (fl owchart) to
an SOP. It then illustrated the completion of that template
with a cleaning and sanitizing procedure. This also involved
a review of the process of cleaning and sanitizing of facilities
for GMP compliance.
4.5 Notes
1. See John DiLollo (2000); also Michelle Rosa (2006);
and Irina Colligon and Michelle Rosa (2007).
2. See the discussion in David Porter (2010).
3. See John Avellanet (2008).
4. See 21 CFR 211.56, Sanitation.
5. See 21 CFR 1271.190, Facility cleaning and sanitation.
6. For similar EU and ICH statements, see Jeanne
Moldenhauer (2009).
