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.
Expanded scope to explicitly include APIs, FPPs, and intermediates
These rules apply to all premises where drugs are manufactured.
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.
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.
New mandatory IQ/OQ/PQ qualification requirements for all equipment
No corresponding clause existed.
All equipment shall be subjected to qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Qualification shall be completed before equipment is used in routine manufacturing.
New mandatory calibration requirements with marking protocol for non-conforming equipment
No corresponding clause existed.
Measuring, weighing, recording and control equipment shall be calibrated and checked at defined intervals using certified reference standards. Equipment that does not meet calibration criteria shall be clearly marked and shall not be used.
New cleaning validation requirement with documented procedures
No corresponding clause existed.
Written procedures shall be established for cleaning of premises and equipment. There shall be validated cleaning procedures to ensure effective removal of product residues, cleaning agents and microbial contamination.
New gowning validation requirement with area-specific procedures
No corresponding clause existed.
Written procedures for gowning shall be established for each production area based on the cleanliness classification. The gowning procedure shall be validated to demonstrate that garments do not introduce unacceptable levels of contamination.
New SOP management requirements with mandatory 2-year review cycle
No corresponding clause existed.
Standard Operating Procedures shall be maintained for all critical operations. SOPs shall be reviewed at least once every two years and updated as necessary. All SOPs shall be readily available at the point of use.
New process validation with three-batch rule and revalidation triggers
No corresponding clause existed.
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.
New OOS handling requirement with 30-day investigation deadline
No corresponding clause existed.
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.
Frequency increased from annual to semi-annual with independence requirement
Self-inspection shall be conducted annually.
Self-inspections shall be conducted at least once every six months by a team composed of experts. The self-inspection team shall include at least one member who is independent of the area being inspected.
New formal CAPA system requirement covering all quality events
No corresponding clause existed.
A Corrective and Preventive Action (CAPA) system shall be established. All observations from self-inspections, complaints, deviations, recalls and regulatory inspections shall be evaluated through the CAPA system.
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.