ICH Q10 is a guideline developed by the International Council for Harmonization (ICH) that provides a comprehensive model for an effective pharmaceutical quality system (PQS).
Key Objectives of ICH Q10 include:
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Annual Product Quality Review
Electronic
Logbook System
Laboratory Information Management System
Manufacturing Execution System
Calibration & Preventive Maintenance
Regulatory Information Management System
Learning Management System
Environmental Monitoring System
Electronic Quality Management System
User Access Management System
Document Management System
Quality Control
System
Cleaning Validation Software
Process Validation
Software