Schedule M Browser
Browse the full text of the Revised Schedule M (2025). We've organized the gazette notification into an indexed, searchable structure complete with plain English explanations for complex requirements.
Part VIII
Self-Inspection and Quality Audits
Self-Inspection Program
A self-inspection programme shall be established to monitor the implementation and compliance with GMP principles and to recommend corrective actions. Self-inspections shall be conducted at least once every six months by a team composed of experts competent to evaluate GMP compliance. Written records of self-inspections shall be maintained. The self-inspection team shall include at least one member who is independent of the area being inspected.
AI Explanation
Do formal self-inspections at least every 6 months using qualified staff. Write detailed records of findings. At least one inspector must be from outside the area being checked to ensure objectivity.
CAPA System
A Corrective and Preventive Action (CAPA) system shall be established. All observations from self-inspections, complaints, deviations, recalls and regulatory inspections shall be evaluated and addressed through the CAPA system. Effectiveness of corrective actions shall be verified. Preventive actions shall be implemented to prevent recurrence of identified issues.
AI Explanation
You need a formal CAPA system. Any problem found — whether in self-inspection, complaints, or deviations — must go through CAPA. Verify that fixes actually work, and put preventive measures in place to stop problems from happening again.