contractpharmaMay 18, 2017
Tag: pharmaceutical manufacturing , UPM
UPM Pharmaceuticals is celebrating the 100-year anniversary of pharmaceutical manufacturing occurring at its Bristol, TN, facility. Pharmaceutical products have been continuously manufactured at its current site since 1917.
In March 1917, S.E. Massengill purchased the site and transformed it into a pharmaceutical manufacturing facility. According to historical records, the Massengill brothers purchased their first piece of manufacturing equipment, a $25 hand-operated tablet machine and began the legacy. In 1971 the site became home to Beecham Laboratories’ North American headquarters. King Pharmaceuticals acquired the site in 1993, which was then sold to Pfizer in 2011. In July 2013 UPM bought the facility from Pfizer.
UPM is an independent contract development and manufacturing organization (CDMO) serving the pharmaceutical and biotechnology industries.
During the 100 years of production at the Bristol site, operations have expanded from a small facility footprint of less than 10,000 square feet and only two small buildings, to a modern campus of over 475,000 square feet and additional warehouse and distribution space of almost 250,000 square feet.
"We are proud of the legacy of the Bristol, TN, site in the history of the pharmaceutical industry," said James Gregory, chief executive officer, UPM. "The success of the products and the growth of the capabilities of the site stand as testimony to the many outstanding employees who have worked here over the past century."
UPM Pharmaceuticals originated as a drug formulation and cGMP laboratory within the University of Maryland School of Pharmacy, and today offers a full breadth of capabilities from early research and development to clinical trial material manufacturing and commercial scale product supply. It is also DEA approved to handle CII-CV manufacturing. The Bristol site has several low humidity manufacturing suites and the ability to handle potent compounds in dedicated suites.
The last FDA audit at the site was in October 2016. It was a general GMP inspection of all systems and a preapproval inspection of a product that the company’s R&D team developed. No 483s were issued and approval of the site to manufacture the product was recommended.
"Obviously, we were quite proud of this result," said Mr. Gregory. "We also have yearly DEA inspections given our capabilities to handle controlled substance products and have had no notice of violations or 'for cause' investigations. UPM is fully committed to quality and manufacturing innovations to assure the timely supply of needed medicines."
According to the company, a new, proactive approach to quality was adopted in 2016 that is client-focused and includes implementation of manufacturing quality assurance (MQA), the use of metrics to evaluate performance and realignment of its laboratory functions to increase both efficiency and responsiveness.
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