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.
good documentation practices
Let us briefly review the critical role that standard ...