Compliance, Quality, Safety and respect for the Environment
The company Management is responsible for providing adequate resources and a continuous supervision in order to assure that the final dosage forms of the pharmaceutical products satisfy customers’ expectations about high quality standards and comply with the regulatory requirements in force.
At the same time, the company Management commits itself to achieve excellence in its employees’ Health and Safety stand as well as for the Environment we operate in ; this Policy is transferred to all employees as well,
In line with ICH Q8, Q9 e Q10, Quality and Compliance are considered a competitive advantage and are based on two basic pillars:
A state of Permanent Preparation for Audits, making all the employees feeling directly involved and responsible for the Quality Systems of their pertinence:
The Quality Assurance is responsible for ensuring that adequate Quality Systems are in place to guarantee that manufacturing, packaging, control, storage and distribution of products are performed in compliance with cGMP and all relevant regulatory requirements
The company Management is responsible for providing adequate resources and supervision in order to satisfy customers’ expectations about high quality standards of products
The Functional Areas are responsible for the creation and maintenance of a working environment able to guarantee that quality, compliance to regulations, safety and environment are of primary importance in all the activities performed
The Lean Quality approach, where Compliance results both effective and efficient thanks to the integration of the Lean (e.g. 5S, Right First Time, Visual Factory, Continuous Improvement) and Quality Risk Management principles with the Quality by Design criteria.
The Quality Control consists of a chemical lab, a microbiological lab and a lab for packaging materials control.
The QC analyses and approves all the raw materials and packaging materials, performs the environmental controls, tests the finished product for authorizing the release. All the finished products arriving form extra-European countries are tested for authorizing the Import according to the regulations in force.
The list of the equipment includes air samplers, autoclaves, dissolution baths, freezers, gas-chromatographers, HPLC systems, laminar-flow cabinets, microscopes with camera and printer, ovens, particle-size analysers, fridges, spectrophotometers (IR, NIR, UV/Visible), Total Organic Carbon analyser and Verification System for printed bar codes.