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.

5 clauses modified10 new clauses added0 clauses removed

All Sections General Premises Equipment Sanitation Documentation Production Quality Control Self-Inspection Personnel

Clause 1.1General

modified

Expanded scope to explicitly include APIs, FPPs, and intermediates

Old Schedule M

These rules apply to all premises where drugs are manufactured.

Revised Schedule M

These rules shall apply to all premises used for the manufacture of drugs, including active pharmaceutical ingredients (APIs), finished pharmaceutical products (FPPs), and intermediates. Every manufacturer shall comply with the requirements of Good Manufacturing Practice as laid down in this Schedule.

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