QMS

IU GTTL manages personnel qualification and role-based responsibilities to support reliable biosafety and testing capabilities.

• Training and Personnel Qualification
• Competency Confirmation
• Role definition
• Access control
• Retraining when procedures, methods, or systems change

IU GTTL controls equipment and computerized systems through qualification, maintenance, access governance, and lifecycle management.

• Calibration and Maintenance
• Qualification Protocol
• Computerized System Validation
• Account and Access Control
• Audit Trail of critical instruments

IU GTTL manages the complete lifecycle of all materials, from initial receipt and secure storage to full traceability and proactive expiration monitoring.

• FIFO (First-In, First-Out) methodology to ensure proper stock rotation
• Risk assessment and Classification Management
• Testing, Release and CoA

IU GTTL controls the laboratory environment and biosafety procedures to reduce the risk of contamination and to support reliable testing.

• Biosafety and contamination prevention
• Laboratory access control
• Cleaning and environmental monitoring

IU GTTL's documentations and records system is designed to meet FDA regulations:

• Controlled issuance and return of documents and records
• Full lifecycle management of documents and records
• Good Documentation Practices (GDP)
• Archive room management

IU GTTL's quality system is aligned with the following regulations：

• cGMP
• 21 CFR Part 11
• 21 CFR Part 58
• 21 CFR Part 210/211
• 21 CFR Part 600/601/610
• FDA Drug Master File