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.
New mandatory IQ/OQ/PQ qualification requirements for all equipment
No corresponding clause existed.
All equipment shall be subjected to qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Qualification shall be completed before equipment is used in routine manufacturing.
New mandatory calibration requirements with marking protocol for non-conforming equipment
No corresponding clause existed.
Measuring, weighing, recording and control equipment shall be calibrated and checked at defined intervals using certified reference standards. Equipment that does not meet calibration criteria shall be clearly marked and shall not be used.