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 training documentation and effectiveness assessment requirements
No corresponding clause existed.
All personnel shall be trained in GMP requirements. Training effectiveness shall be assessed periodically. Training records shall be maintained for each employee including topic, date, trainer name, and assessment results.
Strengthened QA independence with explicit non-delegation clause
Quality Assurance shall be independent of production.
The Quality Assurance function shall be independent of production. The head of QA shall have the authority to approve or reject any material. The QA department shall not delegate its core responsibilities to production or any other department.