Successful inspection by the FDA of Intertek Pharmaceutical Services in San Diego
Californian Bioanalytical Immunochemistry facility successfully completes a seven-day inspection by the United States Food and Drug Administration
Intertek Pharmaceutical Services' San Diego, CA, Bioanalytical Immunochemistry facility has successfully complete a seven-day inspection by the United States Food and Drug Administration (FDA).
In September 2012, an investigator from the FDA visited Intertek's San Diego facility for a routine inspection to assess the facility for overall compliance with Good Laboratory Practice (GLP) regulations. The San Diego facility is a leading GLP compliant laboratory providing development and validation of quantitative ligand-binding assays (immunoassays) for use in PK (pharmacokinetic) and TK (toxicokinetic) studies including immunogenicity and biomarker studies for novel biologics and biosimilars.
During the course of the audit, the investigator toured Intertek's facility over several days, focusing on sample management, equipment and equipment records, archival practices (storage, retrieval and tracking of archived data), and QA reporting functions. The FDA investigator also reviewed multiple reports, including several method validations and sample analysis projects.
Upon completion of the inspection, the investigator reported no findings and Form 483 was not issued.
'Intertek Pharmaceutical Services operates under the most stringent of Quality systems, assuring our clients that the quality of data received will always be of the highest standard,' stated Dr Dominique Gouty, Director of Intertek Pharmaceutical Services in San Diego. 'All laboratory personnel who were interviewed gave professional confident responses related to their jobs and responsibilities.'
'We are extremely pleased with this successful inspection, which confirms Intertek’s commitment to meeting the highest quality standards. It was incredibly gratifying to see the San Diego facility complete such an intense audit with no findings,' added Dr Andrew Swift, Executive Vice President of global operations for Intertek Chemicals & Pharmaceuticals.
