Quality Corner

Good Laboratory Practice

Good Laboratory Practice (GLP) regulations apply to non-clinical in vitro and in vivo safety studies (e.g. toxicology) on regulated products. GLP regulations ensure studies are reliable and reproducible through planning, performance, documentation, reporting, monitoring and archiving.

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, Sekisui XenoTech offers both GLP-compliant and non-GLP studies.

Primary differences between a GLP-compliant and non-GLP study conducted at Sekisui XenoTech can be reviewed by downloading our technical paper located along the right hand side of this page!

Sekisui XenoTech's Quality System

Sekisui XenoTech's Quality System is based on the principles of GLP. All studies are conducted following the same requirements for planning, performance, documentation, reporting, monitoring and archiving. XenoTech products adhere to the same GLP principles with exceptions defined in production SOPs.
 

Sekisui XenoTech's Quality Assurance

Sekisui XenoTech's Quality Assurance Unit (QAU) is committed to ensuring industry and regulatory standards are met or exceeding within our organization. The QAU performs audits and inspections confirming study and product compliance to protocols, SOPs and regulatory standards, as applicable.

The QAU provides timely and accurate compliance feedback; specializing in FDA, EPA and OECD GLP compliance.

The team provides the following services:
  • GLP and non-GLP study audits (per sponsor request)
  • Production audits
  • Computer System Validation audits
  • Method Validation audits
  • Facility audits
  • Process-based audits
  • Supplier audits
  • Identification of best practices through detailed SOP reviews
  • Companywide compliance training

Mission
GLP vs. non-GLP
Our Quality Team
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