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
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Clause 6.2Production
new

New process validation with three-batch rule and revalidation triggers

Old Schedule M

No corresponding clause existed.

Revised Schedule M

Process validation shall be conducted for all manufacturing processes. Three consecutive successful production batches shall be completed as part of the validation exercise. Revalidation shall be carried out whenever there is a change that may affect product quality.

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