Biomedical Engineering Reference
In-Depth Information
POINTS TO CONSIDER
FOR COMMISSIONING AND
QUALIFICATION OF
MANUFACTURING FACILITIES
AND EQUIPMENT
HAROLD S. BASEMAN AND MICHAEL BOGAN
7.1
INTRODUCTION AND BACKGROUND
This chapter presents
points to consider
on the use of quality risk management
and assessments to help the reader make decisions needed to plan, develop, and
conduct more effective qualification efforts. The chapter is not meant to be an
all-inclusive discussion on how to perform installation and operational qualifica-
tion. Nor is the objective of this chapter to present an exclusive and complete
guide to the use of risk assessment techniques for commissioning and qualifica-
tion. Instead, the chapter presents some of the areas where risk assessment can
effectively be used to help develop and implement a sound, efficient qualification
program.
In order to assure that drug manufacturing processes perform as expected
and result in products meeting quality specifications, equipment and systems
supporting those processes must work in a reliable manner. Commissioning and
qualification efforts should be designed to ensure that these systems are designed,
installed, and operating properly.
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