Industrial Operations

The Chiesi Group's production plants are located in three different sites: the Officine Farmaceutiche di Parma (Italy), with 400 staff members, split into the San Leonardo and the via Palermo sites, the Blois-La Chaussée plant in Saint Victor (France), with more than 50 employees, and the Santana de Parnaiba plant (Brazil), with 100 workers.

Parma
The Parma plant is an international supply centre and exports products to over 60 countries. The San Leonardo plant site operates in accordance with the ISO 9001:2000 Certified Quality Management System and has successfully passed a number of inspections carried out by regulatory authorities from many countries, including the US Food and Drug Administration, the Canadian Therapeutic Products Program and the Agenzia Italiana del Farmaco (Italian drug Agency).

The international Good Manufacturing Practice standards, successfully adopted by Chiesi, feature the very latest technologies involving a high degree of automation and product segregation, whilst also guaranteeing maximum levels of safety for employees and respect for the environment.

The careful management of our partnerships with suppliers, who are required to ensure a high standard of service, safety and quality in the Company, requires an excellent level of service in the supply of products to our affiliates and clients. Annual production at the Parma plant totals around 40 million finished packages. The San Leonardo production plant site manufactures solid formulations: tablets and powders for DPI (DryPowder Inhalers), solutions and suspensions for pressurised MDIs (Metered Dose Inhalers) with eco-friendly propellants (hydrofluoroalkane), or alternatively those packaged in sterile unit-dose vials using "Blow Fill Seal" technology for nebulized inhalant therapy (UDV).

The production laboratories in Via Palermo prepare vials of sterile suspensions designed for endotracheal administration (Curosurf), liquid formulations, such as drops and liquids, and nasal sprays. The current capacity for three-shift production of unitdose vials (UDV) stands at over 200 million units per year. MDI production capacity, also operating on three shifts, currently manufactures 15 million aerosol containers and is about to be doubled. The process will be completed by the end of September 2008.

The new production department for the Curosurf sterile suspension has been approved by both European health authorities and the FDA, following a thorough inspection procedure. As a result of investments made to expand the output of plants supplying this active ingredient, production capacity has now reached over 350,000 vials.

By the end of 2008, an automated MDI assembly and packaging line will also become operative. The filling, assembly and packaging lines for the new DPI will also be completed by the end of this year, alongside the extensions made to the office and laboratory premises.

Production and back-up processes (cleaning in place, sterilizing in place) are managed and monitored by means of fully-validated computerised systems. In addition, a new kind of IT framework similar to the Manufacturing Execution System (MES) is being created, in order to further increase automation levels, and a new computerised dispensing system, based on a similar set-up, is already operative. The automation process will continue in 2008 with the arrival of the so-called electronic batch record system.

Blois
Manufacturing capacity at the Blois plant stands at around 5 million finished packages a year. The French production laboratories specialise in blister packaging for capsules and tablets. In 2006, the investments required to enable the Blois site to distribute directly to clients in the French and export markets were finalised, as well as those providing backup for the final stages of the MDI assembly and production processes; refrigerated storage space has been built for these products.

As of 2008, Blois is therefore a fully-fledged Corporate site working alongside the Parma plant as a supplier of the Group's new products (such as MDI formulations) for affiliates and partners alike.

Santana de Parnaiba
Annual production at the Santana de Parnaiba plant totals around 6 million finished packages. The production lines at the plant manufacture solid formulations (tablets) and pressurised solutions and suspensions for inhalant therapy (MDI). Considerable investment has also been made in Brazil to install a new line for MDI production, not only with conventional CFC propellants (which are currently being phased out), but also those using the new HFA alternative. Following the AIFA inspection, which was passed successfully, the new line has been submitted for approval to supply the European market. The Santana plant is therefore also about to begin supplying Corporate products to the Group's various markets.

Technological support
The Corporate Manufacturing Technology department supports Research & Development as the scale of production of new products increases, in the transfer of production from a plant to another, either within or outside the Group, or when a partner decides to manufacture by itself, using technology which has been Chiesi patented.