Page 40 - Introduction QC

GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com

Once a method has been suitably developed, it is
PUBLISHED published in a formal that should be unambiguous and
METHODS easy to follow far an analyst. The published method
should also reference any instrumentation and
corresponding settings.

Once a method is published, it must be validated

according to ICH Q2(R1), or equivalent criteria. This
method validation package should confirm the suitability
VALIDATION of the method. The validation report is generally

submitted to a regulatory agency as proof that the
method is lit for use and validated.

TRANSFER When a test method is suitably validated, it is transferred
TO QC LAB to the QC laboratory for commercial use. At this point,
QC analysts become responsible for the test method.

As part of the transfer, validated test methods must be

verified as to their suitability in the QC laboratory. This
VERIFY generally involves partial validation to confirm that the
SUITABILITY transferred method remains in a validated slate and is
still lit tor use, using the QC laboratory using the

instruments and analysts.

The test method is used for the routine testing of target
USE METHOD products, and if properly validated and transferred,
IN TESTING
should be reliable and robust.

From time to time, methods will require updating under
document and change control. Some reasons for
UPDATE updating include regular updates to pharmacopoeias or
METHODS
improvements to the method itself. Updated methods
generally require partial revalidation. The old method
should then be archived in case it needs to be referred to
at a later date.

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