503B Outsourcing Facilities

Kymanox Sterile Compounding Expertise Summary

For more than a decade, Kymanox has been a recognized leader in the areas of CGMP manufacturing, process engineering, quality assurance, regulatory compliance, validation, and quality control.  Kymanox understands that pharmacies play a major role in the US healthcare system and this industry is undergoing rapid change coupled with difficult economic and regulatory environments.  Ultimately, a patient receiving a sterile product of any kind should have a very high assurance that the product’s safety, quality, and efficacy are as claimed.  In that regard, Kymanox’s mission and the mission of the FDA are very much aligned.

Kymanox has been out-in-front on the nation’s drug shortage crisis ever since the New England Compounding Center tragedy of 2012.  Stephen M. Perry, the founder and CEO, has presented important quality and manufacturing concepts to US Senators and audiences at FDA-attended conferences, including the 2013 BIO International Convention in Chicago.  Kymanox performed a deep-dive analysis of US compounding operations in 2013 with a large research report and helped companies prepare for regulatory changes, much of which eventually materialized in the 2013 Drug Quality and Security Act (DQSA).  Being able to proactively recommend best practices for sterile compounding activities with the DQSA, as well as its eventual enforcement, was a huge advantage to Kymanox’s early pharmacy clients.

Kymanox has extensive expertise in performing FDA-readiness audits for the approvals of new biologics, drugs, devices, and combinations products (e.g., PAI mock audits and remediation to support NDA, BLA, and PMA approvals).  Each year now, Kymanox performs about 10 major mock-FDA audits – all of which are for sterile, injectable products (i.e., parenterals) – in addition to 40 or more other CGxP quality audits in the US and around the globe.  On multiple occasions, Kymanox has worked alongside clients and the FDA during week-long 503B inspections by the FDA.

Kymanox has been retained numerous times to design, commission, validate, and start-up new commercial sterile drug product manufacturing facilities for full compliance to 21 CFR 210 and 211 regulations.  This experience extends to over a dozen different 503B Outsourcing Facilities which must comply to most of 21 CFR 210 and 211.

Kymanox is a top leader in servicing 503B Outsourcing Facilities, as well as those facilities that designate themselves as 503A.  Kymanox has over 30 satisfied pharmacy clients all over the United States – including the very largest companies who carry the 503B designation.  In some cases, Kymanox provided the initial 503B registration support, and in other cases Kymanox helped successfully remediate very challenging 483 Observations and related Warning Letters.  In all cases where Kymanox advisement was followed, clients have had no issues with FDA.  In a small minority of cases where Kymanox advisement was not followed, clients were faced with FDA-mandated recalls and shutdowns.  As such, Kymanox has been able to accurately predict FDA enforcement actions, including actions that are incongruent with guidance and regulations.  In full transparency, Kymanox has elected to part ways with some pharmacies who do not follow critical safety recommendations and will continue to do so in the future.

All Kymanox project work is managed with professional-grade project management and Kymanox’s own PM Toolkit™ is used.  All Kymanox employees have formal training based on principles from the Project Management Institute (PMI) and Kymanox maintains staff certified as Project Management Professionals (PMPs) and Project Management Associates (CAPMs).

With well over 500 years of cumulative experience in CGxP compliance, the Kymanox team is able to cover nearly every relevant topic that may come up during a specific project.  In the unlikely situation we are lacking in-house expertise, help is available from our Kymanox Preferred Partner Network (KPPN) members.


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