EXPERTS IN STERILE PHARMACEUTICAL SOLUTIONS
503B HUMAN DRUG OUTSOURCING
|Providing high-quality sterile preparations that are produced with industry-leading automation and quality control systems.|
Posted By Brian Williamson on Thu, May 22, 2014 @ 17:05 PM
In January, JCB registered with the FDA as an 503B Outsourcing Facility. This registration indicates our commitment to patient safety and acknowledges that a higher level of compliance and oversight is welcomed. We also understand that in order to continue providing sterile compounded products to facilities across the country, it was necessary to align our processes more closely with current Good Manufacturing Practices (cGMP). While JCB has always incorporated cGMP thinking within our facility, it was time to raise the bar again.
In December, 2013, JCB contracted with one of the top cGMP compliance companies in the country, ProPharma Group, to improve overall compliance and robustness of our practices. ProPharma (PPG) performed a gap analysis to determine where we stood in regards to cGMP compliance. After the assessment, JCB contracted with PPG to be onsite at JCB writing new protocols, validating and revalidating equipment, and performing quality studies on JCB’s overall processes. The performance and execution of the project was flawless and PPG performed at a level much higher than expected. While this was only the initial phase of ongoing Continuous Quality Improvement and cGMP compliance, JCB and PPG worked together to achieve the goal that is and has always been priority number one...product reliability and patient safety.