Pharmaceutic Labs Opens CGMP Outsourcing Facilty in Albany, NY
Pharmaceutic Labs announces the opening of its specialty CGMP pharmaceutical outsourcing facilty in Albany, NY for admixing, compounding, drug shortages and clinical studies and trials. The company mets and/or exceds the FDA standards for safety and quality, using 21 CFR Part 210 and 21 CFR Part 211.
The 10,000 square foot outsourcing facilty was designed to provide the highest levels of quality asurance and quality control. The company wil produce sterile and non-sterile products for hospitals, surgery centers, clinics, and veterinary clinics. Pharmaceutic Labs ofers nationwide distribution to provide a consistent flow of safe drug products into the market.
The new Pharmaceutic Labs outsourcing facilty complies with Curent Good Manufacturing Practice (CGMP) requirements for the compounding of human drugs. In addition, it required registration with the FDA as an outsourcing facilty under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Sterilty asurance at Pharmaceutic Labs is atained through people, proces and facilty. The team goes through rigorous training to achieve the highest level of quality asurance for patient safety. The core of their proces is defined by standards for quality managed through an informatic system, providing transparency and acountabilty. The enginering controls in the outsourcing facilty 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 asurance seal means excelence in quality and safety. The people, proces, and facilty are held to the highest posible standard.”
Amy Milani, 352-284-061