FDA Inspects MicroConstants for Compliance with Good Laboratory Practices, No Deficiencies Noted

Bioanalytical and pharmacokinetic specialty Contract Research Organization (CRO) MicroConstants announced today the successful completion of a five-day inspection by the United States Food and Drug Administration (FDA) for compliance with Good Laboratory Practice (GLP) regulations.

 

On September 20, 2012, an investigator from the FDA visited MicroConstants' San Diego facility for a routine inspection to assess the CRO's overall compliance with GLP regulations. During the visit, the investigator toured the facility and laboratory areas and reviewed several method validations, three sample analysis projects, and a pharmacokinetic analysis report. Upon completion of the inspection, the investigator reported zero findings, observations, or recommendations.

 

"MicroConstants aims to have one of the most comprehensive quality assurance programs in the industry," says Jose Buenviaje, vice president of quality assurance and regulatory compliance at MicroConstants. "Annual examinations of our QA programs and bi-annual client surveys allow us to continually evaluate our current quality systems. This FDA inspection further confirms the quality of GLP-compliant services performed by MicroConstants."

 

Over the span of two days, the investigator toured MicroConstants' facility, examining the sample management and reference standard areas, GLP bioanalytical and immunology laboratories, and analytical instrumentation rooms (LC/MS/MS, HPLC). The investigator also performed detailed inspections of the equipment and analytical instruments utilized during the five GLP studies selected for evaluation during the inspection.

 

"I have hosted numerous facility tours over the past 14 years and this was by far the most exhaustive, with exceedingly comprehensive questions and discussions," states David Beyerlein, vice president of global operations at MicroConstants. "It was incredibly gratifying to hear so many positive comments throughout the tour."

 

 

MicroConstants is a GLP-compliant Contract Research Organization (CRO) focused on performing bioanalysis, immunoassays, drug metabolism and pharmacokinetic analysis services to support the drug discovery and development programs of pharmaceutical and biotech companies worldwide. They specialize in method development, method validation, and sample analysis of small molecules, proteins, and peptides using LC/MS/MS, HPLC/UV, and ELISA for preclinical and clinical studies.