Biomedical Engineering Reference
In-Depth Information
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34R
Working with standard
operating procedures (SOPs)
Abstract:
The preceding chapter established the central
role of a standard operating procedure in the regulated
process. The fi rst part of this chapter presents a template
for the development of a SOP, including the relation of a
process map (fl owchart) to the SOP. The second part
illustrates the completion of that template with a cleaning
and sanitizing procedure. This will also involve a review
of the process of cleaning and sanitizing of facilities for
GMP compliance.
Key words:
allowable levels, bioburden, cleaning, GMP
zones, good documentation practices, procedure (SOP),
responsible (party), safety precautions, sanitization.
4.1 Introduction
Let us briefl y review the critical role that standard operating
procedures (SOPs) play in regulated industry:
(a) SOPs are “process controls;” they control the execution
of processes;
34R
