Over recent years, Glatt has gradually extended
its qualification and validation activities. Our experience can
prove invaluable in your risk assessment, when drawing up your validation
master plan, and for all other validation-related activities.
We offer a complete facility qualification
service
Glatt defines qualification as the in-project documentation of
relevant quality activities, i.e. documentation firmly anchored
in the project itself. Our success has shown us to be right. With
its professional and practically-oriented approach, Glatt turns
qualification into a target-oriented process rather than a "never-ending
story". We work in line with the principles of GMP. The Glatt
control system "MegaView", for instance, was developed
on the basis of the GAMP4 life cycle. And it goes without saying
that Glatt control systems comply with the requirements of 21 CFR
part 11.
Glatt offers a variety of different qualification packages for
different requirements. You decide which resources you wish to invest
in qualification or validation, and the degree to which you require
our support.
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Belt speed measurement
at a packaging line |
Press force measurement
at a tablet press |
Our calibration service
Calibration is an essential element of qualification. It is an
underlying requirement for the reproduction accuracy of process
results. We offer the following measurement system calibration services:
Initial calibration
Trained calibration technicians check the critical measurement
circuits and enter the results in the calibration log. You are provided
with work instructions and results.
Recalibration
Repeat calibration at defined intervals ensures that measurement
systems operate within the prescribed limits in the long term. We
offer contracts allowing for the recalibration of measurement circuits
by Glatt at intervals determined by you (typically 6-12 months).
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Glatt
calibration technician at work
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Our calibrations are performed using measuring
devices checked annually for their accuracy |
Definition of terms
Validation
Validation is the provision of objective evidence in agreement
with the principles of Good Manufacturing Practice (GMP) to the
effect that methods, processes, equipment items, materials, work
cycles or systems actually achieve the expected results.
Qualification
Qualification is documentary evidence, on the basis of tests,
and within the framework of a validation process, that the manufacturing
process has the disciplines necessary for the creation of a given
product quality.
Calibration
Calibration is the formal, systematic, documented comparison of
measurement and display accuracy attained by measuring and control
equipment relative to a defined reference system (standard).
Calibration: A measured variable is compared to a reference
variable.
Adjustment: The measurement system is balanced in such a
way that the measured variable deviates as minimally as possible
from the true value (reference value), and is within the tolerance
range.
Verification: A measuring device is verified on the basis
of a statutory regulation. A test is performed to determine whether
the verification-specific regulations, such as verification error
limits, have been breached. The measuring device is additionally
identified by a verification stamp.
During a calibration process, a measuring device can be adjusted.
However, this does not mean that it is verified.
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