June 2013
Intermediate to advanced
374 pages
7h
English
Content preview from Quality Assurance
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4
Working with standard operating procedures (SOPs)
Abstract:
The preceding chapter established the central role of a standard operating procedure in the regulated process. The first part of this chapter presents a template for the development of a SOP, including the relation of a process map (flowchart) 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 briefly review the critical role that standard ...
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