Hanford Support Services - Additional Considerations

Process Control and Validation Department:

The Company maintains a comprehensive process control department that reports to quality assurance. Process control undertakes the activities most often termed “process validation” in the pharmaceutical industry, but at Hanford, they play a role that is far broader than validation alone. Process Control manages all of the Company’s validation activities, including installation, operational and process qualification of all equipment. Process Control also undertakes all protocol writing, the execution of validation studies and final report writing. Many of these reports are used in Hanford’s submissions for regulatory approval of new products or improved processes.

Validation at Hanford is a multi-disciplinary activity, particularly in areas such as process simulation testing of aseptically-filled products and packaging, where employees performance is a critical component in process control and therefore product quality. It is generally recognized that the aseptic production of sterile products is the single most difficult production undertaking in the pharmaceutical industry. The regulatory requirements for demonstrating that an aseptic process is in a validated state-of-control are both rigorous and specific. The Company is required to comply with the same regulatory guidelines and to achieve the same demonstrated levels of performance as Fortune 100 multi-national pharmaceutical companies. For a relatively small company such as Hanford to fully comply with current industry best practices requires a process control discipline capable of operating at a very high level of efficiency.

In addition to validation, Process Control undertakes process improvement initiatives and engages in support of all new product development or line expansion. The scientists in Process Control are also proficient in risk analysis techniques that are so vital to both validation planning and problem resolution with the modern pharmaceutical quality system. Regulations require that each process undergo a periodic, usually annual, reassessment and retesting of process control status. This activity, often known as revalidation, is also the responsibility of Process Control, which maintains the specific written procedures that define the scope of this work.