VERSION HISTORY
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.
Clause 7.3Quality Control
newNew OOS handling requirement with 30-day investigation deadline
Old Schedule M
No corresponding clause existed.
Revised Schedule M
Written procedures shall be established for handling Out-of-Specification results. All OOS investigations shall be completed within 30 days. The batch shall not be released until the OOS investigation is satisfactorily completed.