Qualification and calibration of analytical instruments is a key component of CGMPs
in each of the major regions.
Calibration failures for dissolution instruments have
plagued the industry for many years.
This is not unexpected, since the dissolution test...
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Qualification and calibration of analytical instruments is a key component of CGMPs
in each of the major regions.
Calibration failures for dissolution instruments have
plagued the industry for many years.
This is not unexpected, since the dissolution test is more challenging than many
other analytical tests, since it involves chemical and physical factors that are
changing in a very rapid timeframe.
In the last several years there has been a lot
of change related to qualification of dissolution instruments.
Compendial chapters on dissolution have been harmonized globally, USP introduced a
new format for acceptance criteria for the Performance Verification Test, added a
Toolkit to aid executing the PVT, and FDA (and others) have indicated that Enhanced
Mechanical Calibration (without the use of calibrator tablets) can be an acceptable
approach for qualification of these devices.
This course is designed to provide participants with an understanding of the
requirements for dissolutio
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