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Quality Assurance by G Welty

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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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