Xcelience Completes Successful QP Audit of Production Facility for European Market
March 10, 2007 (PRLEAP.COM) Health NewsTampa, FL March 10, 2007 — Xcelience, LLC, a Tampa-based drug development and manufacturing company, announced today the successful completion of an independent audit of its facility which establishes the company's compliance with European practices. This was Xcelience's third successful audit of this type.
Penn Pharmaceutical Services Ltd, one of the UK's leading providers of fully-integrated pharmaceutical outsourcing services was commissioned by one of Xcelience's sponsors to undertake the audit of the facility. The purpose of the audit was to assess the facility's compliance with European Union standards relating to the principles and guidelines of Good Manufacturing Practice in producing medicinal products for human use.
Xcelience's sponsor commissioned the audit in anticipation of the company's application to the Medicines and Healthcare products Regulatory Agency (MHRA) in London for a Clinical Trial Authorization of a Phase III trial to be performed in Europe.
Paul Thomas, Technical Director at Penn Pharmaceuticals Services Limited said, "We are pleased that our QP and CMC expertise has helped support Xcelience with their European strategy and MHRA application. Having completed a detailed audit of the Tampa-based facility, we found operations to be in general compliance with equivalent standards of EU GMP as described in directive 2003/94/EC. That has enabled us to provide importation services for Investigational Medicinal product manufactured at Xcelience for use in approved EU Clinical Studies."
Derek Hennecke, CEO and President of Xcelience added, "This is not our first successful QP audit, but it is the first time we have been able to show our EU accreditation to new sponsors. We take sponsor project confidentiality very seriously so naturally we are pleased to be able to share some of our successes with the outside world."
Penn Pharmaceutical Services Ltd is a leading provider of outsourced pharmaceutical development services to the international healthcare industry. The company's core business expertise includes a fully comprehensive product development service, which consists of formulation and analytical development, clinical trial manufacturing, packaging and supply management and extensive contract manufacturing. Penn also offers CMC Consultancy and Qualified Person (QP) Services.
Xcelience is a Tampa-based laboratory providing high quality in drug development. The company brings together the industry's most experienced and talented scientists, efficiently moving compounds through the research and development stages to market. Since 1997, the lab has been developing formulations for clients throughout the country. Xcelience's unique corporate structure creates project teams which work intensively with each client, becoming an extension of their own organization into the Xcelience lab.
FOR MORE INFORMATION: www.xcelience.com
Media Contact: Mike Nabors
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