Page 23 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

Phase 2
This phase, overseen by QA, assesses the potential
effects of any proposed change (impact assessment). Of
prime concern is the potential impact on product quality,
reduction, improvement over process controls, and the
IMPACT impact on product registration.
ASSESMENT

If the proposed change is not allowed by GMP, results in
a reduction of product quality, or results in a loss of
process control, the change is not implemented. If the
proposed change improves or restores process control, or
restores product quality, the change management
process progresses to Phase 3.

Phase 3
At this change planning phase, there are generally two
options for change, minor or major, depending on the
change's impact.
APPROVE /
DENY Minor changes are effected by updating documents, and
conducting retraining, if necessary. For major changes,
a documented change plan is necessary that considers
regulatory approvals, validation, training, and
documentation. The change plan must be approved by

QA.
Phase 4
In this phase the change plan is implemented. The
effectiveness of the implementation is verified, usually by

IMPLEMENT QA, and the documentation is finalized. The change is
& REVIEW then closed.

Sometimes, QA may schedule a post implementation
review to assess ongoing control or improvement.

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