Change Management is the system
to control / manage changes to established system / facility It ensures:
§
There is no impact to product quality due to the change.
§
The system/facility is maintained in a validated State.
Change
management module deals with initiation, evaluation, approval / rejection,
implementation and disposition of changes
§ Prior approval: Change is
proposed before or during the regulatory approval of the product.
§
Post approval: Change is proposed for product that is approved by
Regulatory Authority.
§
Not Applicable: Change proposals which does not impact the product
Change Classification:
Initiator shall
classify the change based on the priority and criticality of the change from
the following list of values.
§
Emergency-Major
§
Emergency-Moderate
§
Emergency-Minor
§
Normal-Major
§
Normal- Moderate
§ § Normal- Minor
Major:
Change that has
a substantial potential to have an
adverse effect on the identity, quality, strength, purity or potency of a drug
product as these factors may relate to the safety
or effectiveness of the drug
product.
E.g.: Change in the Drug
Product formula
Moderate:
Change that has
the moderate potential to have an
adverse effect on the identity, quality, strength, purity or potency of a drug
product as these factors may relate to the safety
or effectiveness of the drug
product.
E.g.: Change in the Analytical
method
Minor:
Change that has
a minimal potential to have an
adverse effect on the identity, quality, strength, purity or potency of a drug
product as these factors may relate to the safety
or effectiveness of the drug
product.
E.g. Change in the SOPs
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