Facility, Equipment & Process Excellence

1. Facility Design & Validation Support

• Conceptual and detailed layout design support for new or modified pharmaceutical drug product manufacturing facilities

• Equipment and clean utility layout planning in compliance with cGMP and workflow efficiency

• Support for qualification and validation strategy (DQ, IQ, OQ, PQ)

2. cGMP Assessment – Facility, Equipment, Process & Practices

• cGMP assessment of the facility and infrastructure

• Comprehensive evaluation of manufacturing processes, equipment, engineering utilities, aseptic practices, and smoke studies

3. Support for New Technology Implementation & Validation

• Assistance with the implementation and validation of new technologies in manufacturing and quality systems

4. Onsite/Virtual Training

• Customized training programs for Manufacturing, Quality Assurance, Engineering personnel, and other stakeholders