Pharmaceutic Labs opened its specialty CGMP pharmaceutical outsourcing facility in Albany, New York, for admixing, compounding, drug shortages and clinical studies and trials.
The 10,000 square foot outsourcing facility was designed to provide the highest levels of quality assurance and quality control, according to company officials. The new Pharmaceutic Labs outsourcing facility complies with Current Good Manufacturing Practice requirements for the compounding of human drugs. 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 company meets and/or exceeds the FDA standards for safety and quality, using 21 CFR Part 210 and 21 CFR Part 211. In addition, it required registration with the FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act.
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."
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, a company spokesperson explained. 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.