Old vs New Schedule M
Explore the exact textual changes between the old Schedule M and the Revised Schedule M (2025). Our comparison tool highlights added and removed requirements, making gap analysis easier for your facility.
Frequency increased from annual to semi-annual with independence requirement
Self-inspection shall be conducted annually.
Self-inspections shall be conducted at least once every six months by a team composed of experts. The self-inspection team shall include at least one member who is independent of the area being inspected.
New formal CAPA system requirement covering all quality events
No corresponding clause existed.
A Corrective and Preventive Action (CAPA) system shall be established. All observations from self-inspections, complaints, deviations, recalls and regulatory inspections shall be evaluated through the CAPA system.