The whole production process is closely monitored by a quality control system, with completely new facilities and equipment for all types of pharmaceutical needs, and uses the latest test techniques.
AXONE® wants to reach the highest levels of quality assurance in development, production and control of the medicines through a Plan-Do-Check-Act documented methodology. Its effectiveness is assessed from the perspective of ongoing improvement.
The company’s vision and ambition is evident and its aim is to focus on high quality standards and sustained growth. It has invested in a R&D laboratory that is fitted out with small scale replica of the production equipment, it has qualified employees; top quality facilities
suitable for developing its own products; and the ability to boost the technology transfer process. The excellent services offered, the flexibility, as well as an accurate perception of needs and innovation all make AXONE® a solid company that has the capacity to answer its clients’ needs on time and with 100 percent professionalism.
In order to complete the process AXONE® integrates a Qualified Person (QP), responsible to ensure that each batch of medicinal product has been manufactured and checked in accordance with the requirements of its marketing authorization and current EU Good Manufacturing Practice guidelines before it is released within the European Union (EU).
This service is particularly important for the cases where a batch has had different stages of production or testing conducted at different locations
or by different manufacturers, and where an intermediate or bulk production batch is divided into more than one finished product batch. It also covers the release of batches which have been imported to the EU both when there is and is not a mutual recognition agreement between the Community and the third country.
