ABC Announces Completion of EPA GLP Audit
By Business Wire News
By Business Wire News
ABC Laboratories announced today that a GLP facility inspection conducted by the United States Environmental Protection Agency (EPA) at both Columbia facilities was completed Friday, February 27. At the conclusion of the 4-day inspection, ABC received an EPA Inspection Observations form (form EPA 3540-38) for each of our facilities indicating “No GLP deficiencies identified.”
“Positive inspection outcomes by regulatory agencies provide our clients with peace of mind that ABC’s quality systems and processes are compliant with established Good Laboratory Practice regulations,” said John D. Bucksath, ABC President & CEO. “They also present important opportunities to obtain qualitative feedback on our operations. We are pleased to be able to share with our clients that ABC continues its exceptional record for GLP compliance with EPA regulations.”
Last week’s inspection was unique in that U.S. regulators were accompanied by Mexican counterparts from Entidad Mexicana de Acreditación (EMA). The international visit was part of a training exercise to facilitate implementation of the Organization for Economic Cooperation and Development (OECD) Council Decision regarding Mutual Acceptance of Data (MAD). U.S. regulators traveled to Mexico for similar training in 2007. “It was a real honor to have been selected by the EPA to host this international visit,” said Bucksath.
About ABC Laboratories
Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a privately held Contract Research Organization that provides expert development and analytical testing services to the pharmaceutical, biopharmaceutical, animal health, crop protection and chemical industries. The company helps its clients expedite time-to-market by devising phase-appropriate development strategies, and supports all stages of product development, registration and commercialization with a broad range of GLP- and CGMP-compliant testing, including custom synthesis, radiolabeling and environmental assessments. ABC employs more than 400 scientists and support personnel, and has its headquarters in Columbia, Missouri.
For additional information, visit http://www.abclabs.com or contact Kristein King at (573) 777-6209.
Kristein King, 573-777-6209