Biopharmaceutical facilities continually experience the combined challenges of efficient, uninterrupted production, while maintaining consistent regulatory compliance. Daily manufacturing demands can promote actions such as short-term patches on deficiencies, retention of inefficient processes and technologies, deviation from SOPs, rushed expansions and/or process modifications, and potential problems being ignored.
CRB’s Fit Facility Program provides a proactive and systematic health check of facilities. It is designed to reveal risks that contribute to failed batches, product/delivery shortages, product contamination, and ultimately regulatory violations. As a world leader in facility design, engineering and construction, CRB brings 30+ years of expertise in bioprocessing design, consulting, and driving the industry forward. In addition, CRB has co-authored many of the standards that serve as the basis of biopharmaceutical manufacturing. CRB’s Fit Facility team has provided fully integrated remediation and safeguard solutions with proven results that exceed industry benchmarks. We are experts at identifying deficiencies and potential risks in order to protect your business from costly failures - providing full service positioning for your success.
How Fit Facility Works
The Fit Facility program starts with assessments at periodic intervals to build systematic risk mitigation and peak performance into your culture. This program aligns with objectives to modernize a site, evaluate and optimize processes, rework equipment, and retrain personnel.
The Fit Facility program can be tailored to your unique circumstances. The preferred proactive assessment identifies discrepancies with industry best practices, deficiencies requiring action, reliability issues, and areas where problems may be imminent.
Our Fit Facility assessment report includes corrective actions that will achieve compliance, mitigate failures and optimize productivity – all aligned with your business strategy and budget.
Leveraging our industry-leading experience in facility design and construction, CRB can execute all phases of corrective and preventative remediation to realize your success.
Your Fit Facility is fully prepared for regulatory audits and optimized to deliver a competitive advantage. Ongoing assessments make certain peak performance becomes part of your culture.