Dedicated to Quality

A Note from our Quality Director

We are a growing company that examines our processes continuously for ways to improve our productivity and efficiency without compromising quality. Every employee is empowered to contribute to the quality and productivity of the company through ongoing education and training programs on regulatory requirements, current Good Manufacturing Practices and local procedures. We measure our success by the quality of our products and services, productivity of our operations, and the satisfaction of our customers.

Our Core Quality Systems

• Validation programs in place
• Equipment qualifications IQ,OQ,PQ
• Strict process controls
• Master procedure documentation and control
• Specifications development and management
• Work flow control: receiving, production and shipping
• Batch record development and documentation
• CAPA program (corrective and preventive action)
• Personnel training program – dedicated trainers
• Robust in-process testing
• Rigorous management of change control

Quality System Values

• EPC quality systems approach begins with senior leadership reporting directly to the CEO.
• All operations are supervised by full-time quality control specialists and undergo rigorous validation and safety checks.
• All production runs are in compliance with cGMP and other FDA regulations.