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The fine chemicals production facility of PCAS Finland Oy started its operations in March 1960 as part of Leiras Oy. It was the first plant manufacturing active pharmaceutical ingredients in Finland. The plant served well until the end of 1989, and a new state-of-the-art plant was started to operate in October 1983. In this cGMP level facility, there are 4 separate reaction modules with glass-lined reactors of different sizes ranging from 250 to 6000 litres, and a special controlled room area for final processing operations. We also have high level analytical equipment for development and quality control (for example NMR, HPLC, HPIC, HPLC/MS, GC/MS), and a highly qualified local R&D team (18 persons) supported by the technical expertise of PCAS Group. Quality Assurance We aim at achieving and maintaining high quality in our products and services. We have a strong team in our QA operations, dedicated to qualification and validation. PCAS Finland Oy has filed different Drug Master Files and Certificates of Suitability of Monographs of the European Pharmacopoeia. Customers and health authorities have inspected our operations regularly, and the FDA has been auditing the company since 1982. A high cGMP level is applied throughout the company operations.
Environmental, health, safety & security (EHS) issues have been consistently emphasized in our operations. Our EHS actions are developed according to the Finnish laws, decrees and regulations, and the Responsible Care program, in which we have taken part since 1994. Our EHS system includes the organisation and guidelines designed for the planning, implementation and management of issues related to occupational and process safety and environmental protection. |
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