Quality Assurance personnel are trained in performance excellence and proven, data-driven improvement techniques to identify and correct root causes in the event of any nonconformance issue.
PrePak's quality systems approach begins with senior leadership reporting directly to the CEO. This commitment to compliance with both current Good Manufacturing Practice and customer requirements ensures a proactive approach.
The leadership system provides a mechanism for organizational learning and process control. All associates are empowered change agents. They are knowledgeable and trusted high-performers.
PrePak complies with 21 CFR, Parts 210 and 211 for the processing, packing and holding of bulk drugs and finished pharmaceuticals
Full Validation Program
- Master Validation Plan
- Equipment IQ,OQ,PQ
- Process
- Cleaning
- Facilities / Environment
- Computer
CAPA Program (Corrective and Preventive Action)
Personnel Training Program – Dedicated Trainers
100% QA In-Process Verification Program
Management of Change Control Program
