Sort Change Impact
Classify GMP changes by likely quality impact so review depth follows risk.
Sort each proposed GMP change by likely quality-impact review depth. Low impact Moderate impact High impact Correct a spelling error in a training slide without changing meaning or required behavior. Update warehouse aisle numbers on a site map while material status controls remain unchanged. Move a controlled worksheet from QA office storage to a point-of-use holder in the processing room. Change preventive-maintenance frequency for a non-critical utility based on two years of history. Revise packaging-room waste flow to separate empty cartons before reconciliation. Qualify a new API supplier for a commercial tablet product. Replace a validated manual cleaning step with…
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