Mastelli S.r.l. have always set aside a high proportion of their investments for improving both the quality of their production and, generally speaking, the quality of all their activity. In order to succeed in the best possible way, in recent years Mastelli Srl introduced first a Quality Management System and subsequently certification issued by an independent Certification Body, that testifies proper compliance by the Company with the highest quality standards in the whole chain of activities in the pharmaceutical field – research, development, production and marketing – as well as in the processes of scientific communication aimed at underpinning the appropriate use of its pharmaceuticals and in the governance system, structured for the purpose of ensuring compliance with the regulations in force (existing regulations).
This aim was achieved first of all through:
- careful selection of their personnel (investment in human resources)
- up-dating of all the operational procedures for manufacturing, management and training, and with the related checks
- achievement and maintenance of the two ISO 9001 and 13485 certifications
- achievement of Doping Free Play Sure certification
- issue of a Code of Business Ethics
- the replacement for modernisation of various production equipment and the refurbishment for modernisation, or implementation of production departments with the relevant validations
- assessment of initiatives to improve environmental sustainability
The basis of Mastelli’s development and consolidation on the market consists also of ensuring that the quality requisites are met to a high level.
Mastelli’s Quality Management System is an integrated GMP-ISO system. Indeed, it complies with all the applicable GMP requirements, those of ISO 9001 and ISO 13485 standards and those of the European regulation on medical devices, in accordance with the relevant legal requirements.
In this perspective to optimise and with the aim of pursuing continuous improvement, a series of organisational and technical actions are applied to all company departments:
- Compliance with the binding /regulatory requisites relating to the fields of Pharmaceuticals/Medical Devices/Cosmetics and to the product/service supplied
- Compliance with the management requisites
- Compliance with the customers’ requirements and expectations and with those of all the interested parties
- Achievement of higher levels of competitiveness
- Continuous improvement of the quality of the product/service supplied
- Continuous improvement of the effectiveness and efficiency of the Quality Management System
- Up-keep of the Certifications of the Quality Management System and of the GMP Certificate.
The company is authorised to manufacture drugs and raw materials for pharmaceutical use and manufacture Medical Devices. Through constant updating and sensitisation of personnel, and the involvement and active participation of the whole company, it is possible to pursue a truly effective Quality Policy. The General Management is also committed to verifying the cultural and regulatory updating of its medical sales representatives (ISF) through a specific certification.
The defined goals to support the Quality Management System aim at:
- complying with ethical standards, laws and regulations
- finding innovative solutions for improving the wellbeing of individuals, transforming commitments to research into therapeutic proposals
- ensuring the quality of the products and services proposed
- monitoring the processes, products and services offered, with a view to improving them continuously
Ever since the Company was founded, Mastelli complies with and promotes a set of fundamental principles that characterise the manner in which the Company works in all its activities, both internally and outside its own structure. Among these, a central role is attributed to its commitment towards quality and business ethics: according to this philosophy, continuous improvement of the Company’s dynamics and attention paid to the needs of Patients and of the Scientific Community are considered the key to success for sustainable development.
Safety, too, has significant specific importance for Mastelli, and it is for this reason that correct application of the Management System to every field in the Company is ensured by the people in charge of the various different areas, through the involvement and the participation of all the Employees. Full sharing of the principles of quality and safety during the work is, indeed, essential for strengthening a culture aimed at prevention and reciprocal respect, and for maintaining and developing orderly and safe working conditions.