ISO 17025 vs. GLP for in vitro testing

December 6th, 2013

ViVitro Labs Inc. is frequently asked if we comply with GLP (Good Laboratory Practice) regulations. ViVitro Labs conducts bench tests that do not involve animals, plants or microorganisms, therefore GLP regulations are not applicable. ViVitro Labs’ Laboratory Services (excluding PIV Flow Visualization) are ISO 17025 accredited and follow best laboratory industry practices. This paper clarifies ISO 17025 vs. GLP for in vitro testing and the benefits that ViVitro Labs’ ISO 17025 accreditation offers to our clients.

ViVitro Laboratory services are governed by a mature Quality Management System (QMS) that outlines management and technical requirements of an accredited laboratory, and as such is certified to ISO/IEC 17025 for the test methods that are based on the ISO 5840 standard. ViVitro Lab ’s A2LA Scope of Accreditation includes the mechanical testing of cardiovascular implants including heart valve substitutes.

ViVitro Labs’ laboratory personnel are proficient in verification of hydrodynamic performance, durability testing, and assessment of flow fields for heart valve substitutes. Testing is conducted with equipment manufactured by ViVitro Labs, leveraging equipment validation over decades of testing and familiarity of regulatory protocols.

GLP- Good Laboratory Practice

GLP– 21 CFR part 58 Good Laboratory Practices for Nonclinical Studies first introduced in 1978 in the US, refers to a quality system prescribed for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including medical devices for human use.

Summary

ViVitro Labs has chosen ISO 17025 accreditation since it is the most appropriate and relevant approval for our laboratory services and product testing. We recognize the benefits of GLP compliance, however the regulation is not applicable to the type of testing our laboratory performs.

For further details or clarification please contact us at the main ViVitro Labs address: 455 Boleskine Road, Victoria, BC, V8Z 1 E7 , Canada.

Virginia Anastassova, RAC, B.Sc.
Regulatory Affairs Manager/Senior QA Specialist
(Acting ViVitro Quality Manager)