The revised schedule replaced a largely premises-and-equipment rulebook with a quality-system approach. Large manufacturers had to comply first; micro, small and medium enterprises were given more time. With those transition periods behind us, Revised Schedule M is now in force for every manufacturer, large or small — and CDSCO and state licensing authorities inspect against it.
What changed for manufacturers
- A pharmaceutical quality system — management responsibility for quality, with deviations, CAPA, change control and investigations handled as one connected system.
- Quality risk management — decisions on quality based on documented, proportionate risk assessment.
- Product quality review — a regular review of each product’s batches, deviations, changes, complaints and results to confirm the process remains consistent.
- Supplier qualification — approved suppliers of starting and packaging materials, quality agreements, and audits based on risk.
- Qualification and validation — equipment, utilities, processes, cleaning and computerised systems qualified or validated.
- Documentation and records — controlled SOPs, specifications, master formulae and batch records, with good documentation practice throughout.
- Quality control and stability — documented testing, stability programmes, reference standards and calibrated instruments.
- Complaints, recalls and self-inspection — systems to handle complaints, trace and recall product, and audit your own compliance.
- Computerised systems — controls for systems used in GMP activities, including access, data integrity and audit trails.
For many Indian plants, the hardest part is not any single requirement but the volume of linked evidence: a deviation that should lead to a CAPA, a change that should update an SOP and retrain people, a supplier whose qualification decides whether a material can be ordered. Paper and disconnected spreadsheets make those links invisible. That is the gap a connected platform closes.