Quality and EHS

Quality Policy

At Angelini Pharma we are committed to the consistent delivering of highest quality products to meet and exceed our Patients’, Consumers’, Customers’ and Stakeholders’ expectations, in full compliance with applicable regulations, codes and standards.

A quality-focused culture and a consistent quality management practice are foundational for our purpose and vision. Our guiding principles are embodied in this Quality Policy:

EVOLVE OUR CULTURE

• Our inclusive leaders are accountable and committed to maintaining an effective Quality Management System (QMS) by means of appropriate and efficient systems, processes and procedures in place. They commit to acting as enablers for inspiring and driving quality-focused behaviours and ensure decision-making based on what is best for product quality, as well as patients’ and consumers’ safety.
• Each person, regardless of their role, is a significant contributor in fostering a quality mindset. We ensure that all employees have appropriate education, training, skills and experience to carry out their work competently according to applicable regulations and standards, as well as follow our procedures.
• We aim at spreading the quality culture at all company levels, promoting integration and collaboration of global and local organizations to embed compliance into efficient operations.

DELIVER THE CORE

• We adopt a Risk Management Integrated System aimed at guaranteeing that any risk associated with our products is promptly detected, evaluated and either reduced to a minimum or nullified. Actions are timely identified in order to prevent potential product quality or compliance risks. Processes for escalating issues to ensure product integrity, as well as patients’ and consumers’ safety, are in place and consistently used.
• We are focused on providing quality guidance and operational support to ensure that a robust and resilient global supply chain is in place for medicinal products, guaranteeing treatment access for patients, even during major public health threats.
• All relevant third-party providers and suppliers, carrying out services on behalf of Angelini Pharma, are selected based on our quality and compliance criteria in order to ensure that our quality and safety standards are fully satisfied. We ensure an effective oversight of partners and mutual participation in defining the expected level of service.

FIT FOR THE FUTURE

• Our digital journey is accelerating to boost the use of digital systems, records and data that continuously improve the performance, efficiency, quality and traceability of our processes.
• We maintain a special focus on our R&D and pipeline construction to make sure that our scientific evolution is supported by the consistent compliance of our QMS, as well as by the adequate development of necessary technical and quality skills of our people.
• We leverage Angelini Pharma sustainability strategy and roadmap for integrating sustainability requirements into quality management practices, to make sure we provide high quality products and solutions that also preserve the environment and promote the growth of community close to our operations.

Our quality objectives are clearly defined, monitored and regularly reviewed to ensure that performance and standards of conduct meet the relevant high-quality expectations of our Patients, Consumers, Customers and Stakeholders.

Our Quality Policy is implemented through a company Quality Management System and is shared with all our workers. The Quality Policy is regularly reviewed in alignment with the company purposes and vision in which we develop, produce and distribute our products.

Quality Policy

Our environmental and occupational health and safety (EHS) policy

Angelini Top Management, in line with the Vision, the Mission of the Company and the Organization, Management and Company’s Control Model pursuant to own Ethic Code, establishes its Environmental and Occupational Health and Safety (EHS) Policy, referring to the activities of research and development, industrialization, production and acquisition of products manufactured by third parties, marketing, logistics and distribution, typical of its business and concerning all products placed on the market, and undertakes to implement it and to keep it updated so that it is always appropriate to nature, size and impact of its activities, with the aim of continually improving of the environmental and health and safety performance at work, as well as undertakes to disseminate it to all levels of the organization and make it available to Interested Parties.
With this EHS Policy, Angelini traces the guidelines, states its own principles defined as commitments and sets its own objectives to achieve the results expected from the management system.
The concrete implementation of this Policy is supported by the whole organization.

OUR EHS PRINCIPLES

• We want health, safety and well-being to be always guaranteed to all people in the Organization and to the Interested Parties.
• We want to pursue the protection of the environment and the protection of health and safety in the workplace and for this reason our actions and initiatives are aimed at eliminating dangers, reducing risks and limiting any consequences for people, for the environment and for properties.
• We want to operate in full compliance with the regulatory requirements regarding quality, environment and health and safety in the workplace, always maintaining a relationship of maximum collaboration and transparency with workers, with public authorities, with the external community and with anyone who may have influence on Environment, Health and Safety Management System.
• We undertake, through the Organization, to deploy adequate resources with clear and well-defined roles and responsibilities and we undertake to provide everyone with the appropriate skills to be able to achieve our objectives of protecting the health, safety of workers and the environment.
• We believe that the culture of health and safety in the workplace and environmental protection must be developed at all levels of the Organization because the quality of our products, the protection of the environment, the protection of health and workplace safety is the result of the reliability of our processes, decisions and the work of each of us.
• We work for the excellence of our processes, products and services, always taking the utmost account of the health and safety of workers and the environmental sustainability of the activities and products placed on the market.
• We undertake, by setting long-term continuous improvement objectives and specific objectives, to implement concrete programs to improve the health and safety conditions of our workers, environmental protection and significant environmental aspects connected with the activities carried out, in order to ensure the sustainability of our development.
• We promote continuous dialogue with all Interested Parties, in order to understand and meet the relevant needs and expectations for increasing environmental and health and safety performance.

OUR EHS GOALS

Angelini Top Management establishes the following macro objectives for the environmental and health and safety of workers, which will be periodically reviewed, together with the results achieved to ensure their relevance, in order to continuously improve the performance of the management systems:

• Promote safe behaviors and the reporting of dangerous behaviors in order to continually improve accident rates and prevent accidents;
• Preventing accidents and improving accident rates also through the implementation of protection and prevention measures resulting from the application of models for identifying the basic causes that generated the accidents;
• Maintain an open dialogue with contractors and suppliers by committing them to implement or maintain conduct consistent with this Policy;
• Guarantee an adequate level of healthiness in the workplace by ensuring that the levels of occupational exposure of workers are always suitable in relation to the level of risk of the substances handled;
• Reduce direct and indirect environmental impacts, adopting the best available technologies and virtuous behavior with particular attention to:
  • Containment of the waste produced, favoring recycling or recovery, also through an
    increasingly careful and effective differentiation at origin;
  • Containment of specific energy consumption and water resources available;
• Encourage in all employees the growth of the sense of belonging and satisfaction in lending their work and active participation in the achievement of objectives also by strengthening the communication processes of participation and awareness.

Environmental, Health and Safety Policy