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 cleaning validation requirement with documented procedures
No corresponding clause existed.
Written procedures shall be established for cleaning of premises and equipment. There shall be validated cleaning procedures to ensure effective removal of product residues, cleaning agents and microbial contamination.
New gowning validation requirement with area-specific procedures
No corresponding clause existed.
Written procedures for gowning shall be established for each production area based on the cleanliness classification. The gowning procedure shall be validated to demonstrate that garments do not introduce unacceptable levels of contamination.