End-to-End GMP Compliance Solutions for Building International Standard Modern Facilities
1. Design Phase: URS review, Cleanroom layout optimization (personnel flow/material flow/contamination control)
2. Construction Validation: DQ/IQ/OQ/PQ implementation with focus on critical utilities (HVAC/water systems)
3. Quality System Establishment: Quality manual/SOP preparation, Computerized system validation compliance
1. Cost Optimization: Ensure new facilities/workshops meet Chinese/international GMP hardware requirements while balancing applicability, practicality, cost-effectiveness and development needs.
2. Smart Factory: Integrate MES/EMS systems to achieve automated data collection.
3. Regulatory Foresight: Maintain in-depth understanding of regulations to guarantee hardware compliance.
1. Pharmaceutical enterprises establishing new commercial production bases
2. Enterprises upgrading existing production workshops