Frequently Asked Questions

Self-inspections must be conducted at least once every six months. This is a significant change from the previous Schedule M which required annual self-inspections. The inspection team must include experts competent in GMP evaluation, and at least one member must be independent of the area being inspected. Written records of all findings must be maintained.

A formal Corrective and Preventive Action (CAPA) system must be established. All observations from self-inspections, complaints, deviations, recalls, and regulatory inspections must be evaluated through CAPA. The effectiveness of corrective actions must be verified, and preventive actions must be implemented to stop recurrence. CAPA activities must be documented with timelines and responsibilities.