Quality Policy

AB-BIOTICS Quality, Safety and Data integrity policy

AB-BIOTICS S.A. is a company a leading biotechnology based on research, development, intellectual
protection and the distribution of their own exclusive biotechnological solutions through a Business to
Business (B2B) and Business to Consumer (B2C) models.

Our company aims to establish itself as a benchmark of value and profitability in the European biotechnology sector. We work to improve the health of people developing products and providing services that support a healthy life and help to prevent and treat diseases.

AB-BIOTICS has a multidisciplinary team founded by Miquel Àngel Bonachera and Sergi Audivert. The
organization combines the talent of young, dynamic and highly qualified professionals with professionals
with extensive international experience and success in the business and biotechnology world.

  • Vision: AB-BIOTICS aims to establish itself as a benchmark of value and profitability in the European biotechnology sector.
  • Mission: AB-BIOTICS works to improve the health of people developing products and providing services that support a healthy life and help to prevent and treat diseases.
  • Values:
    • Innovation: Generate new ideas that help improve human health.
    • Teamwork: Work together with enthusiasm, focusing on a common goal and benefiting from all
      the synergies generated by the collaboration.
    • Responsibility: Make responsible decisions, ensuring that our efforts contribute to the company’s
      objectives.
    • Respect: Treat people with dignity and confidence and listen to their ideas.
    • Competitiveness: Demonstrate a tireless spirit focused on the pursuit of leadership and
      excellence in our sector.
    • Professional development: Promote continuous learning and the acquisition of new skills and
      competencies within our teams.
    • Social Commitment: Help translate advances in biotechnology into solutions that can improve
      human health.
    • Flexibility: Quickly adapt to changing environments to move towards the company’s goals.
    • Respect for the environment: Being a good corporate citizen, helping to improve the quality of
      life of our society

AB-BIOTICS SA. assumes the commitment to apply a Quality Management System in accordance with our commitment to the safety, compliance and quality of our products and services, as well as to guarantee and implement a culture of safety and food safety.

The commitment of the General Management is manifested in the implementation and maintenance of this Quality Management System that guarantees the suitability of our processes, in a sustainable and robust way, through continuous improvement programs in our products and services.

The entire organization, headed by the General Management, assumes the commitment to:

  • Promote Quality Management and risk prevention and occupational health. Developing training
    activities so that all personnel know, participate and apply the Quality Management System and at the same time allow continuous improvement in the development of their functions, such as:
    • The importance of the implementation and development of the Quality Management
      System, safety and food safety practices.
    • Knowledge of food safety hazards and the importance of food safety and hygiene by all
      company workers.
  • Ensure open and clear communication among all company workers, within an activity and between
    consecutive activities, including communication of deviations and expectations.
  • Effectively assign roles, resources and responsibilities to staff and the company. Endorsing the
    availability of sufficient resources to guarantee the quality and safe and hygienic handling of food or other products.
  • Offer quality and safe products for the consumer, guaranteeing quality in all phases of production
    based on FSSC22000, APPCC / HACCP (Hazard Analysis and Critical Control Point) and NCF / GMP (Good Manufacturing Practice)
  • Introduce the concept of “food safety culture” by promoting food safety by increasing awareness and improving the behavior of workers. In accordance with EU Regulation 382/2021, management
    commitment will include:
    a) Ensure that roles and responsibilities are clearly communicated within each food business
    activity;
    b) Maintain the integrity of the food hygiene system when planning and implementing any
    changes;
    c) Verify that controls are carried out in a timely and efficient manner and that documentation
    is up to date;
    d) Ensure that staff receive adequate training and supervision;
    e) Ensure compliance with relevant regulatory requirements;
    f) Encourage continuous improvement of the company’s food safety management system,
    taking into account, where appropriate, the evolution of science, technology and best
    practices.
  • Implement an effective system for Food loss and waster control, maximizing food production while
    minimizing loss & waste, ensuring food system sustainability according FSSC 2200 standard.
  • Ensure compliance with legislation and other requirements that are applicable to the company in
    relation to Quality and Risk Prevention.
  • Ensure open and clear communication among all company workers, within an activity and between
    consecutive activities, including communication of deviations and expectations.
  • Identify the needs of our customers and meet their requirements to achieve their full satisfaction.
  • Ensure that subcontractors and suppliers apply the same management principles.
  • Communicate this policy to the entire AB-BIOTICS team and collaborators as well as to anyone who
    requires it.

Data integrity

AB BIOTICS S.A. undertakes to provide the necessary infrastructure (technical and human resources) to
ensure data integrity throughout the entire product cycle.

Data integrity affects all company personnel and therefore, AB BIOTICS S.A. ensures annual training for all personnel. This training is related to data integrity in order to comply with the key elements: ALCOA+
AB BIOTICS S.A. has an internal document management procedure in which controls are defined to prevent communication errors as well as guidelines that allow correct manual transcription, thus ensuring that the personnel follow the corresponding procedures in the manufacture of pharmaceutical specialties and food products and Provides evidence of compliance with the standard by documenting the information.

In the case of computerized systems, AB BIOTICS S.A. It uses computer systems that can be validated
according to GxP regulations, in addition to keeping track of paper documentation (where applicable), so that correct traceability of the data can be carried out.

In order to proceed with proper data integrity compliance, Quality Assurance carries out a systematic review of all the equipment/systems that provide data. Through a risk analysis, the criticality of each risk is assessed, and the appropriate measures are established to minimize it.

Any incident related to data integrity, other than falsification, will be dealt with through the deviation system.

In the case of detecting falsified data, the Management will be notified immediately so that it can proceed with the appropriate actions.

Ref.: POLI-001
Version: 5.0
Published date: 22-07-2024 10:41:38 (UTC/GMT +01:00 – Europe/Brussels)
Expiration date: 22-07-2025 10:41:38 (UTC/GMT +01:00 – Europe/Brussels)