Introduction
DOC-M88-EXX157_V17_04.2019 7 / 96
1.2 Performance Verification in GxP Regulated Areas
GxP is a general term for Good Practice quality guidelines and regulations. These guidelines
are used in many fields, including the pharmaceutical and food industries.
The titles of these good practice guidelines usually begin with "Good" and end in "Practice",
with the specific practice descriptor in between. GxP represents the abbreviations of these ti-
tles, where x (a common symbol for a variable) represents the specific descriptor. Examples
are GMP for Good Manufacturing Practice and GLP for Good Laboratory Practice.
Performance specification and verification are mandatory parts of the equipment qualification
(EQ) process as defined by GxP regulations. If your laboratory is not required to comply with
GxP regulations you may skip this section.
For instrument qualification Bruker AXS recommends the adaptation of the specifications and
procedures provided in this booklet into your in-house EQ system according to the following
schema:
Table1.2: Instrument performance verification as part of equipment qualification
Performance Verification Equipment Qualification
Defines the functional and operational
specifications
Establishes that the instrument is received
as designed and specified and that it is
properly installed
Demonstrates that the instrument will
function according to the operational
specifications
Demonstrates that the instrument will
function according to a specification
appropriate to its routine use
To Next Page
Loading...
Need help?
General
