The accreditation attests that the site’s vivaria and various chemistry and pathology laboratories comply with international standards designed to ensure the quality and comparability of preclinical drug safety and toxicology data.
Guido Jacobs, who led the inspection team, said that the site “has best practices in place for conducting GLP [good laboratory practices] studies which are supported by sophisticated systems and a well organized site.”
The Belgian team also deemed that two ongoing trials being undertaken at the site, and three previously completed clinical trials, meet with the OECD’s GLP guidelines.
For CRL, which established the Shanghai lab in late 2008, the award is a key part of efforts to develop the facility into a centre excellence for both local and international pharmaceutical industry customers.
CEO James Foster claimed the site is the first in China to be certified by an OECD country and explained that the award “marks a significant milestone in our commitment to strategically partner with our clients globally to accelerate their drug development programs.”
The 60,000 sqft facility has previously been deemed compliant with guidelines set out by both US and Chinese state drug regulators and the US Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
Contract model marketing and distribution service
In other news, CRL has launched a new contract marketing and distribution service for genetically modified animal models for drug research.
In addition to managing sales, supply and distribution of animal models on its customers’ behalf, the contract research organisation will cryopreserve embryos to provide clients with enhanced “model security.”
“Our team of trained professionals will handle all of the logistics behind circulating your strain, including processing orders, coordinating shipments, making sure all necessary legal documents have been executed and facilitating payments.”