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Quality Assurance by G Welty

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3

The role of critical review in the revision of procedures

Abstract:

This chapter addresses changes to processes and the revision of standard operating procedures (SOPs). Emphasis is put on the necessity of SOP revisions. An illustrative problem is presented – an example of a laboratory weighing procedure and the development of a corrective action and preventive action (CAPA) project. Procedural changes in the example are evaluated and reviewed for regulatory compliance. The management of change depending upon risk assessment is considered.

Key words

calibration

CAPA plan

change management

complexity

critical review

criticality

real-world challenge

risk assessment

3.1 Introduction

Given the ubiquitous changes in technology, procedures ...

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