ACTIVE
in Quality
QUALITY
SYSTEM
Our Quality System is fully compliant with GMP and ICH guidelines.
The quality area is made up of Quality Assurance and Quality Control functions for each site, supported by a corporate Regulatory Affairs function.
Our production sites are regularly inspected by a multitude of international customers and by health authorities such as the Italian AIFA, US FDA, ANVISA Brazil, PMDA Japan. Our plants strictly follow corporate Q.A. directions, which are in full compliance with GMPs and ICH guidelines.
An intensive audit program allows us to keep our quality system up-to-date with the latest in the industry.
DMFs are available for each commercial product. All the manufacturing processes and analytical methods are duly validated.
Health, Safety
and Environment
We are committed to embracing the United Nations’s 2030 agenda and its 17 Sustainable Development Goals (SDGs), promoting it as a reference and guide for the development of a strategic approach to sustainability in businesses. Trifarma’s activities follow high ethical standards and in compliance with all regulatory and sector requirements, laws, regulations, as well as Trifarma’s internal policies.
The same level of commitment is required by Trifarma from all its suppliers.
We are inspired by the global environmental, social and governmental strategy which focuses on the areas considered of importance for our company and the interested parties.
To strengthen and improve our social, environmental and ethical performance we decided to parter with Ecovadis. The assessment is a starting point to track Trifarma’s progress over time. Lately we’ve been engaged in the rationalization of the use of resources, taking actions to improve efficiency and reduce the use of energy, gas and water.
Organizational Model
The organization, management and control model adopted on the basis of the provisions contained in arts. 6 and 7 of Legislative Decree no. 231/01, constitutes to all effects the internal regulation of the Company: the Model is proposed as a fundamental tool to raise the awareness of all employees and all stakeholders (suppliers, customers, commercial partners, etc.), called to adopt correct and transparent behaviour, in line with the ethical values that inspire the Company in pursuing its corporate purpose. With this Model, we aim at the affirmation and dissemination of a corporate culture based on legality, as an indispensable prerequisite for lasting economic success. The Model is also aimed at spreading a culture of control, which must govern all the decision-making and operational phases of the company, in full awareness of the risks deriving from the possible commission of crimes.
The achievement of the aforementioned purposes takes the form of the adoption of suitable measures to improve efficiency in the performance of business activities and to ensure constant compliance with the law and rules by intervening, mainly, on the processes of formation and implementation of the Company’s decisions, on preventive and subsequent controls, as well as on information flows, both internal and external.
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