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SOURCE Unique Pharmaceuticals, Ltd.
Industry-Leading 503 B Outsourcing Facility Receives Industry Certification
TEMPLE, Texas, Feb. 19, 2014 /PRNewswire/ -- Unique Pharmaceuticals, Ltd., an FDA-registered 503 B compounding pharmacy outsourcing facility, today announced it has achieved certification under the LDT Health Solutions, Inc. Compounder Verification program (LDT-CV®), becoming the first national facility to receive the designation.
The LDT-CV program is a voluntary, annual and independent verification process designed to help compounding pharmacies ensure they are meeting all prevailing statutes, rules and regulations governing sterile preparations. The program is administered by LDT Health Solutions, Inc., a New Jersey-based healthcare consulting firm founded by pharmacists with more than 80 years of pharmacy experience.
"As the compounding industry changes following the passage of the Drug Quality and Security Act, we recognize the value of being part of the progress in regulatory and third-party oversight," said Unique Pharmaceuticals President Travis Leeah, RPh, MBA. "Unique's goal is to stay ahead of the curve in meeting and exceeding industry standards. Being the first national facility to receive LDT-CV certification is tremendous validation of our already robust quality management system."
The LDT-CV program is designed for compounding facilities who follow USP General Chapter <795>, <797> and applicable Current Good Manufacturing Practices (cGMP) standards to determine their level of compliance through a third-party audit process. LDT-CV certification helps compounding facilities communicate their performance in functional areas like policy and procedures, documentation, regulatory compliance, staff training and education, sterility and environmental monitoring, supervision of employees and production facility condition.
Unique voluntarily participated in this annual self-assessment encompassing more than 225 data points and will undergo both announced and unannounced audits and an onsite visit to maintain its LDT-CV certification.
Unique is licensed in 47 states and registered with the FDA. The company maintains or exceeds industry standards for quality and sterility through its Quality by Design program, which focuses on rigorous in-process testing and implementation of key process controls. The company continues to make significant investments in technology, training and human capital to ensure it provides sterile preparations of the highest quality.
In January, Unique became one of only a few compounding pharmacies nationwide to voluntarily register with the FDA as a Human Drug Compounding Outsourcing Facility.
About Unique Pharmaceuticals, Ltd.
Unique Pharmaceuticals, Ltd., (UPI) is a FDA-registered 503 B compounding pharmacy outsourcing facility dedicated to improving quality of life and providing trusted compounded preparations for clinics, hospitals and surgery centers throughout the United States. UPI has more than 15 years of industry experience and is ISO 9001:2008 certified, VAWD (Verified-Accredited Wholesale Distributors) accredited, USP Chapter 797 compliant, the only national outsourcing facility to be CV certified by LDT Health Solutions and follows applicable GMPs (Good Manufacturing Practices). The company is headquartered in Temple, Texas, and is committed to delivering quality, assurance and peace of mind with every solution. For more information, please visit www.upisolutions.com or call 888-339-0874.
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