K-Patents PR-23 for K-Patents - Manual (Page 7)

© Copyright K-Patents 2011. All rights reserved.
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This Instruction Manual Appendix covers K-Patents Pharma Refractometer PR-23-AC,
and the Laboratory test cuvette LTC. Using these allows accurate measurements of liquid
concentration to be obtained in compliance with pharmaceutical industry requirements.
Validation of an analytical method is the process, by laboratory studies, that the performance
characteristics of the method meet the requirements for the intended analytical applications.
The Laboratory test cuvette LTC is designed as an additional off-line testing and validation
tool for use with the Pharma Refractometer PR-23-AC.
Qualification is a subset of the validation process that verifies the Pharma Refractometer
instrument performance before it is placed in-line in a regulated environment (Figure 1.1).
System suitability tests are used to verify that the accuracy, repeatability and reproducibility
of the refractometer are adequate for the analysis to be performed. After all qualification
checks have been performed and the required validation standards have been met, the
Pharma Refractometer can then be installed in the production process for in-process control.
DESIGN
QUALIFICATION
INSTALLATION
QUALIFICATION
OPERATIONAL
QUALIFICATION
PERFORMANCE
QUALIFICATION
TIMING AND APPLICABILITY
Prior to purchase of a new
model of instrument
At installation of each
instrument (new, old or
existing unqualified)
After installation or major
repair of each instrument
Periodically at specified
intervals for each
instrument
EXAMPLE ACTIVITIES
Assurance of
manufacturer’s DQ
Description
↔
Fixed parameters Preventive maintanance
and repairs
Assurance of adequate
support availability from
manufacturer
Instrument delivery
(Instrument, manuals etc.)
Verify calibration and
accuracy Validation
Establish practices
to address operation,
calibration, maintenance
and change control
Preliminary instrument
performance valuation
(fitness for purpose)
Utilities/Facility
(are prerequisites met?
↔
Environment
Assembly and installation
Network and data storage
←
→
Secure data storage,
back-up and archive
Installation verification
(initial testing after
installation before
operational qualification)
↔ Instrument function test ↔ Performance checks
Figure 1.1 Qualification process steps.
K-Patents Products for
the Pharmaceutical Industry