회사 소식 What Is The GMP Compliance Request For Modular Cleanroom

By integrating compliance into every stage of modular cleanroom design, operation, and maintenance, pharmaceutical manufacturers can leverage the flexibility of these facilities while upholding the highest standards of product safety and quality.

Modular facilities require a structured validation approach that includes:

• Installation Qualification (IQ): Verify equipment and systems are installed correctly per specifications
• Operational Qualification (OQ): Confirm systems operate within predefined parameters
• Performance Qualification (PQ): Demonstrate consistent performance under actual production conditions
• Retesting and Recertification: Schedule periodic revalidation to account for the flexible nature of modular environments

Maintaining compliance in modular cleanrooms requires a proactive approach:

• Implement a corrective and preventive action (CAPA) system to address deviations
• Conduct regular internal audits and mock inspections to identify gaps
• Stay updated on regulatory changes specific to portable manufacturing facilities
• Maintain comprehensive documentation trails for all processes, tests, and modifications