Facility & Quality Assurance
Our products and services are all managed from our headquarters in Kansas City, KS, USA. This facility was purpose-built and custom-designed to support our contract services, research and development and product preparation, storage and distribution.
Always Ready for Audits: Emphasis on Quality & Regulatory Compliance for Contracted Preclinical Studies
Our Quality Assurance Unit (QAU) is committed to ensuring industry and regulatory standards are met or exceeded within our organization. We frequently welcome representatives from client companies to visit our lab to tour our facilities and see for themselves the high standards of quality we are proud to maintain. The QAU performs audits and inspections confirming services and product compliance to protocols, SOPs and regulatory standards, as applicable. Quality Control is performed independent of the QAU by qualified staff.
The QAU provides timely and accurate compliance feedback; specializing in FDA, OECD and MHLW GLP compliance.
The team provides the following services:
- GLP study audits
- Non-GLP study audits (per sponsor request)
- Production audits
- Computer System Validation audits
- Method Validation audits
- Facility audits
- Process-based audits
- Vendor and Supplier audits
- Maintain the CAPA and deviations report system
- Identification of process improvements through detailed SOP reviews
- Identification of best practices through reviews of industry and regulatory guidance and trends
- Company-wide compliance training
Our Quality System is based on the principles of GLP. All studies are conducted following the same requirements for planning, documentation and archiving. Each study’s performance, reporting, monitoring and archiving duration are specific to the sponsor’s requirements. All SEKISUI XenoTech products adhere to the same GLP principles with exceptions defined in production SOPs.
Foundation in Principles of Good Laboratory Practice (GLP)
Good Laboratory Practice (GLP) regulations apply to non-clinical in vitro and in vivo safety studies (e.g. toxicology) intended to support applications for research or marketing permits on regulated products. GLP regulations ensure studies are reliable and reproducible through planning, performance, documentation, monitoring and reporting.
Regulatory agencies in the United States, Europe and Japan do not require compliance with GLP regulations for in vitro drug metabolism and drug interaction studies. Published industry guidance on the design of drug interaction studies does however emphasize that these studies should be conducted with high standards of quality, ensuring the reproducibility of data. For this reason, we offer both GLP-compliant and non-GLP studies.
Our Quality Team
Shane De Büchel, RQAP-GLP, Quality Assurance Manager
Mx. De Büchel is the Quality Assurance Manager at SEKISUI XenoTech, LLC. Shane is responsible for overseeing all aspects of SEKISUI XenoTech’s quality and compliance improvement efforts, such as developing and administering the quality program. In this role, they are a working manager that also leads the operation of the organization’s Quality Assurance Unit and assures all aspects of the organization’s business conform to SEKISUI XenoTech’s quality standards and regulatory expectations including applicable Good Laboratory Practices (GLP) regulations. Shane has approximately 10 years of quality assurance experience in the regulated pharmaceutical industry, including a year at EAG laboratories (formerly ABC Labs). Shane is also a member of the SEKISUI XenoTech Safety Committee. Mx. De Büchel received a BA degree in Biology from the University of Missouri.
Tim Patterson, ASQ CQA, CQM, Quality Assurance Auditor II
Mr. Patterson is a QA Auditor II at SEKISUI XenoTech, LLC. As such, Tim monitors the compliance of the vendors/suppliers, protocols, SOPs and facility. In this role, he performs audits independently, while continuing to promote quality across all areas at SEKISUI XenoTech. Mr. Patterson assists the other members of the QAU department. Tim has over 20 years of experience working in GMP and GLP regulated environments. Mr. Patterson received his BS degree in Secondary Education from the University of Kansas.
Tanya Milewski, Quality Assurance Auditor I
Mrs. Milewski is a QA Auditor I at SEKISUI XenoTech, LLC. Tanya helps assure compliance with SOPs, federal regulations and industry standards. This includes conducting facility and process based inspections and study audits. Mrs. Milewski is continuously training in additional QAU service areas at SEKISUI XenoTech. She has previous experience in a regulated industry including two years at Bayer and a summer internship at a pharmacy. Mrs. Milewski received a BA degree in International Relations & Business from Cottey College while pursuing pre-medical and pre-pharmacy courses after which she received an Associates in Science degree.