G-CON Manufacturing’s autonomous cleanroom PODs are a major part of achieving cGMP compliant processes and facilities. Our clients expect impeccable validation and qualification services.
Bryan, TX and Downingtown, PA (PRWEB) July 10, 2014
G-CON Manufacturing, Inc. and Concordia ValSource, LLC today announced the signing of a global service and cooperation agreement between the two companies. The agreement bolsters G-CON’s POD offering by providing its customers the renowned service and support of Concordia ValSource in the validation and qualification arena, thus furthering the goal of G-CON clients to have cGMP facilities completed and running in a fraction of the time required for traditional and stick built facilities.
“G-CON Manufacturing’s autonomous cleanroom PODs are a major part of achieving cGMP compliant processes and facilities. Our clients expect impeccable validation and qualification services,” stated Maik Jornitz, COO of G-CON Manufacturing, Inc. “With the cooperation agreement with Concordia ValSource, we are now able to supply such service. Concordia ValSource and its team of highly specialized experts are a well-known entity in the industry, and we are happy to have them as our supporting partner.”
The validation services provided by Concordia ValSource will entail all necessary testing and documentation needed to meet regulatory requirements of achieving a cGMP facility when PODs are deployed for a specific process step or into a facility. Such validation work and knowledge is critical and requires the in-depth know-how that ValSource has provided for years.
“To be maximally effective in your craft, a company must focus on its core competences. G-CON Manufacturing’s core competence is to design, manufacture and deliver autonomous cleanroom PODs. We do not have expertise in validation and qualification as does ValSource, therefore we negotiated this agreement which establishes a great synergy between our two companies with two different but complementary skill sets,” Jornitz added.
“We believe that the use of innovative technologies, such as pre-constructed cleanroom PODs, are a key to more effective manufacturing processes and meeting modern biopharmaceutical product supply challenges. This approach and alliance allows for optimal, standardized, risk based approaches to qualification and validation, which Concordia ValSource has developed and advocated, resulting in improved outcomes for our clients and the industry,” expressed Hal Baseman, COO and Partner.
Effective immediately both companies will work closely in existing and forthcoming projects and will support each other to serve their client base in the best possible way.
About G-Con Manufacturing:
G-CON was founded to address the fact that existing systems and methodologies for constructing biomanufacturing and personalized medicine suites were neither affordable nor flexible enough to meet the rapidly changing market's needs. G-CON's founders have significant experience in designing, building, operating, and maintaining a variety of traditional biomanufacturing facilities. They are familiar with the excessive cost to build, lack of flexibility, and high expense to maintain these traditional facilities and have leveraged this experience to create the G-CON POD™ solution. Moreover, the G-CON team understands that future facility designs must be multipurpose and repurposable, instead of fixed and specialized with ineffective capacity utilization. For more information, please visit the Company's website at http://www.gconbio.com.
About Concordia ValSource:
Concordia ValSource and ValSource, LLC are Consulting firms specializing in the qualification of bio-pharmaceutical healthcare product manufacturing and laboratory facilities and the validation of related processes. We strive to create risk and science based tools and solutions for our clients that simplify complex issues and allow for knowledge transfer and client self-sufficiency. Our services include, process and facility validation plan generation, approach and protocol development, study execution, result analysis, and remediation consultation. ValSource has been providing these services to the pharmaceutical, biologics, and medical device industry for 20 years, and boasts one of the largest resource and project bases in the U.S.