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.
Added specific prohibitions for nearby contamination sources and design requirements
The factory building shall be situated in clean surroundings.
The factory building(s) for manufacture of drugs shall be situated in clean and hygienic surroundings. There shall be no open sewage, drain, public lavatory or dumping ground in the immediate vicinity. The premises shall be designed to minimize the risk of errors and permit effective cleaning and maintenance.
New clause specifying production area surface requirements including coved junctions
No corresponding clause existed.
Production areas shall be of adequate size for orderly and logical placement of equipment and materials. Working and in-process areas shall be adequate to prevent cross-contamination. Walls, floors and ceilings shall be smooth, free from cracks, and designed with coved junctions for easy cleaning.
Detailed HVAC requirements added including HEPA filters with 6-month testing mandate
Adequate ventilation shall be provided.
Adequate ventilation shall be provided with air control facilities including filtration, temperature, humidity and pressure, as appropriate to the product being manufactured. HEPA filters shall be installed for sterile manufacturing areas with integrity testing performed at regular intervals not exceeding six months.