Construction is well under way for a 6,000 square-foot Good Manufacturing Practice (GMP) laboratory that will be a key component of the new UC Davis Institute for Regenerative Cures, a facility supported by the California Institute for Regenerative Medicine.

This highly-specialized laboratory is being built as part of the institute’s $62 million renovation project in an existing building on UC Davis’ Sacramento campus. It is designed to encourage scientific collaboration among the university’s researchers as well as investigators from other institutions whose work requires the particular capabilities of a GMP lab. Under the experienced guidance of GMP lab director Gerhard Bauer, the facility is expected to be operational in late fall of 2009.

 Guiding Principles

Pass-throughs allow spatial and temporal sparation of products as requested by FDA in the pre-facility meeting.

• Adherence to GMP regulations as required by the FDA

• Precisely followed Standard Operating Procedure

• Strict Quality Control (QC) and Quality Assurance (QA), with each being done by different individuals

• Testing of final products according to FDA guidance and requirements 
• Rigorous personnel training and proficiency testing
• Meticulous documentation and record keeping
• Readiness for audits

GMP Laboratory Goal 

• The manufacture of quality products for clinical application