Pharmaceutical GMP Compliance Audit

Conduct a GMP compliance audit for {facility_name} manufacturing {product_types}. Regulatory framework: {regulations}. Last FDA inspection: {last_inspection}. Observations: {previous_observations}. Audit: 1) Facility design, HVAC, and environmental controls, 2) Equipment qualification and maintenance programs, 3) Process validation lifecycle approach, 4) Raw material testing and release procedures, 5) In-process controls and monitoring, 6) Laboratory operations (method validation, OOS investigations, data integrity), 7) Documentation practices and electronic records (21 CFR Part 11), 8) Deviation, CAPA, and change control systems. Classify findings by risk level and provide FDA inspection readiness score.