Facility & Quality Assurance
Our Facility
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.
Facility Specifications
- Updated existing facility in 2015
- 41,500 ft2 space
- Restricted-access, secure facility
- Backup systems for essential laboratory equipment, freezers and technology infrastructure
- On-site generator with automatic transfer switching during power failure
- On-site, secure, restricted-access archives
- Waterless fire suppression for the archive and server areas
- Servers backed up nightly, continuous monitoring of temperature and status
Laboratory Specifications
- Occupies 40% of building space
- UV-free lighting
- Positive pressure HEPA filtered supply air in cell culture labs
- HEPA filtered Class II biosafety cabinets in cell culture labs
- Negative pressure with HEPA filtered exhaust in biohazard lab
- Seamless epoxy floors
- Key equipment and rooms continuously monitored for temperature
- Specialized hazardous waste room with mechanical exhaust and 2 hour firewall
- HEPA filtered balance enclosure with external exhaust
Always Ready for Audits: Emphasis on Quality & Regulatory Compliance for Contracted Preclinical Studies
Quality Assurance
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
Quality System
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 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
Anita Habibi, Quality Assurance Manager, RQAP-GLP
Anita graduated from Kansas University with a BS in Genetics. She ensures all facility and process audits as well as any study specific audits are conducted. Anita is also responsible for assuring test facility management that the company is compliant with GLP regulations and that any issue will be immediately reported to management as appropriate. She additionally assists clients during their inspection of our facility and make sure all their findings are responded in an appropriate and satisfactory manner.
Tim Patterson, ASQ CQA, CQM, Quality Assurance Auditor II
Mr. Patterson is a QA Auditor II at XenoTech, LLC. As such, Tim monitors the compliance of the GLP facilities, protocols, SOPs and facility. In this role, he performs audits independently, while continuing to promote quality across all areas at 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, RQAP-GLP
Mrs. Milewski is a QA Auditor I at 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 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.
Do your studies need to be GLP? Read more about the differences between GLP and non-GLP below:
Quick Read
To GLP or not to GLP?
Deep Dive
GLP vs Non-GLP Application comparison technical paper
