Successful FDA & AIFA inspections for Procos cGMP production
Press Release | Procos S.p.A.
MAY 12, 2016
Cameri, Italy: – Leading Italian contract manufacturer (CMO) Procos has undergone a successful series of regulatory inspections over the past three months.
The inspections have taken Procos a series of significant steps forward to establishing full Good Manufacturing Practice compliance (cGMP) at its new manufacturing facility.
Three sets of inspectors, working with Procos’ internal QA and regulatory compliance teams, have focused on the new Procos 4,000 square meter workshop at Cameri that has enabled a 40 per cent expansion in the company’s manufacturing capacity.
The new facility also hosts new technology platforms to enable more innovative and creative solutions for demanding markets like oncology.
FDA and AIFA
The first inspection, carried out by the US Food & Drug Agency (FDA) in late February, examined authorization to manufacture in the new multipurpose unit, along with a general cGMP audit.
The second, by AIFA, the Italian Medicines Agency, was aimed at establishing correct conditions before authorizing activation of Procos’ new production unit R10, which will manufacture active pharmaceutical ingredients (APIs). AIFA inspectors also carried out a site-wide audit for a general approval of Procos GMP compliance.
Finally, in late April, the Italian Ministero della Salute health ministry performed a further GMP audit focusing on production of veterinary APIs.
Expansion of cGMP manufacturing capacity is a core element of an overall Procos investment and growth strategy, focusing on its principle markets in North America, Europe and Japan as well as ‘pharmarging’ markets across Asia.
Global market APIs
“With all three inspections now successfully completed, we are now authorized to manufacture our global market APIs in the new R10 production unit, significantly expanding our manufacturing capacity,” said Sales & Marketing Director Kingo Yamashita.
Procos S.p.A. is an Italian Contract Research and Manufacturing Organization (CRO, CMO) that specializes in development, scale-up and production of active ingredients and advanced intermediates for the pharmaceutical industry.
Procos is an important member of the international CBC Group, headquartered in Japan. This network provides Procos with global reach, reinforced with subsidiary sales offices in the USA, Slovakia, Germany and India.
Over 70 years, Procos has built up a comprehensive range of technologies and capabilities to provide high quality products and services that have been widely accepted in worldwide pharmaceutical markets. It continuously develops and adds unique generic APIs and key intermediates to its product portfolio.
Procos’ two core business sectors are the development and supply of high potency active ingredients (HPAPIs) and GMP advanced intermediates along with contract manufacturing services.
Procos manufactures more than 30 products, mostly under uniquely designed synthetic methods and under strict regulatory compliance management. In contract manufacturing, Procos provides related services for the pharmaceutical industry acting as a CRO/CMO for custom synthesis on exclusive base, supporting customer from early clinical stage up to full -scale commercial production. Development services include IP analysis expertise and effective patent challenge skills.
Innovation is a driving force of Procos’ activities. The company’s products are based on patented technologies and cost-effective processes. Procos chemistry expertise is focused on the most complex organic reactions, including organo-metallic catalysis, multi-catalytic hydrogenation, Enantioselective and hazardous chemistry.
Kingo Yamashita, Sales & Marketing Director, Procos SpA
Tel: +39 0321 642211
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