Kedrion, a biopharmaceutical company specialising in the development, manufacture and distribution of plasma-derived products, is one of the major participants in the fifth edition of Forum on Health Risk Management taking place in Arezzo (Italy) until November 26th.
In particular, Kedrion took part in the meeting of November 23rd called “Safety of blood-derived products”, chaired by Aldo Ozino Caligaris, National President of FIDAS (Federazione Italiana Associazioni Donatori di Sangue). Dr Elisabetta Tosi, QA Plasma Release manager at Kedrion, gave a speech called “Plasma as the raw material for the production of blood-derived products: risk assessment and risk management”.
The subject at the centre of the debate, attended by Italy’s greatest industry experts, is now particularly relevant after amending the law as a result of the implementation of the 2009 EU Act which has remarkable impacts on the general production and distribution of blood-derived products and especially on the definition of specific rules to ensure fair market competition and product safety.
As a matter of fact, Act 219/2005, as amended by such EU act, strengthens, on one side, the principle of national self-sufficiency, thus laying the grounds to increase the amount of plasma collected in Italy, while on the other side it extends the number of contractors that may supply the processing service, thus enabling EU-based companies to work under contracts for the Italian National Health Service. In addition, this Act lays the conditions to create a collection system based on European quality standards that may be applied all over the national territory.
Kedrion has always been a pioneer in claiming that the growth of competition is a favourable fact the whole System will benefit from, and believes it is essential for the Italian companies to have perfectly clear rules and timelines and to be treated in the same way as the foreign competitors, especially in the strategic provisioning activities. In this new scenario, the goal of consistently introducing the quality standards for plasma collection, as laid down by the European regulations, in all Italian regions becomes a priority as well.
Kedrion believes it is essential to clearly define the process the new players will have to go through to work on the Italian market, mainly to provide a high-quality service to all the players involved in the System and above all to guarantee the safety and effectiveness of the product made from Italian donors’ plasma. In this new scenario, all stakeholders will have to make their contribution to make sure Italian plasma will be processed in the foreign sites to the highest quality and safety standards, which are the same as those currently expected of Italian producers.
Quality and Safety at Kedrion
The Kedrion Group has a distinctive market position because of its wide product range, its cutting-edge plants, which are internationally certified according to GMPs (Good Manufacturing Practices), and its relentless commitment to quality and innovation. To ensure product and process effectiveness and safety, Kedrion has developed a multi-step programme – Kedrion Quality Program (KQP) – based on the steady monitoring of every step in the production process.
As well as having drawn up and implemented its own Code of Ethical Conduct, Kedrion has been awarded the SA 8000 Certification for Social Accountability, the Certification in the Area of Scientific Representation (based on the guidelines issued by Farmindustria, the Association of Pharmaceutical Industries) and Certifications for its Quality Management System and Environmental Management System.
In addition, in 2010, Kedrion has been awarded Quality Standards of Excellence, Assurance, and Leadership (QSEAL) certification. QSEAL certifies quality systems in the provisioning and monitoring of own plasma and is issued by PPTA – Plasma Protein Therapeutics Association, a board of worldwide relevance for the plasma fractionation industry.