Pharmaceutic Labs Opens CGMP Outsourcing Facility In Albany, NY

ALBANY, N.Y., Oct. 20, 2014 /PRNewswire/ -- Pharmaceutic Labs announces the opening of its specialty CGMP pharmaceutical outsourcing facility in Albany, NY for admixing, compounding, drug shortages and clinical studies and trials. The company meets and/or exceeds the FDA standards for safety and quality, using 21 CFR Part 210 and 21 CFR Part 211.

The 10,000 square foot outsourcing facility was designed to provide the highest levels of quality assurance and quality control. The company will produce sterile and non-sterile products for hospitals, surgery centers, clinics, and veterinary clinics. Pharmaceutic Labs offers nationwide distribution to provide a consistent flow of safe drug products into the market.

The new Pharmaceutic Labs outsourcing facility complies with Current Good Manufacturing Practice (CGMP) requirements for the compounding of human drugs. In addition, it required registration with the FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Sterility assurance at Pharmaceutic Labs is attained through people, process and facility. The team goes through rigorous training to achieve the highest level of quality assurance for patient safety. The core of their process is defined by standards for quality managed through an informatic system, providing transparency and accountability. The engineering controls in the outsourcing facility include sterile aseptic practices for the newly built state-of-the-art ISO 7 cleanrooms and ISO 5 equipment. Ernesto Samuel, CEO explains, “At Pharmaceutic Labs, our quality assurance seal means excellence in quality and safety. The people, process, and facility are held to the highest possible standard.”

SOURCE Pharmaceutic Labs

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