Known as a Qualified Person (QP) Audit, the process validates that Frontage product development, analytical testing, manufacturing facility, and quality systems are in compliance with EU Good Manufacturing Practices (GMPs). Importantly, there were no major observations noted during the audit.
European regulations require a QP Audit to be successfully completed prior to use of clinical materials in human clinical studies within the EU.
“The completion of this successful QP Audit is an important achievement for Frontage,” said Dr. Song Li, Chairman and CEO of Frontage Laboratories, “While we have had solid tracking record with FDA inspections, this EU QP Audit assures us and our clients that we remain compliant with GMP regulations in both the US and EU markets.”
The QP Audit was completed Nov. 16, 2011, on behalf of a Frontage client that will soon launch EU clinical studies for a promising drug candidate. Earlier this year, Frontage manufactured a drug product for the client’s early stage clinical testing. After helping achieve the client’s early milestones, Frontage was asked to assist in launching the drug’s EU clinical program. The third party QP Audit recommends release of the clinical trial material for the EU study.
Frontage Laboratories, Inc. is a global contract research, development and manufacturing organization, offering a full range of pharmaceutical R&D services. Frontage operates in the US and China, using one seamless GXP platform. Frontage runs three Phase 1 Clinical units, a 72-bed Phase 1 Unit in Hackensack, NJ, a 120-bed Phase 1 Unit in Zhengzhou, Henan Province China, and a-80 bed Phase 1 Unit in Changchun, Jiling Province China. Frontage has an AALAC certified preclinical animal facility in Pennsylvania, where it also maintains bioanalytical and CMC facilities. In Shanghai and Beijing, China, the company also operates bioanalytical and CMC facilities. As a rapidly expanding CRO with ten years of success providing high-quality GXP services, Frontage has established an international standard in pharmaceutical product research, development, quality and management systems.
Frontage Labs, Inc.