Revised Schedule M — India’s updated GMP, notified in December 2023 and aligned with WHO GMP — is now enforced through risk-based inspections. A gap checklist turns the schedule into a site walk: what is in place, what evidence you can show, what is missing, who owns it and by when.
What the checklist covers
- Quality system and management review, risk management, product quality review and self-inspection.
- Deviations, CAPA, change control, OOS, complaints and recalls.
- Documentation, batch records, data integrity and computerised systems.
- Suppliers, materials control, dispensing and packaging reconciliation.
- QC specifications, review, stability and instruments.
- Training, validation, batch release — and premises, utilities and equipment.
Topic references are to the main subjects of Revised Schedule M; confirm detailed requirements against the published text and the latest CDSCO notices.