Slider quality

Quality comes first

Quality

Quality is the backbone of our company and drives any activity in development, production, distribution and pharmacovigilance, required to ensure that a medicinal product is safe, effective and acceptable to patients.

To achieve and maintain high quality standards, a Quality System is in place, defining standards and internal rules commensurate with the complexity of the activities to be performed.

Any activity with impact on the quality of medicinal products is regulated by procedures, containing operating instructions to be followed in each of such activities. Personnel undergoes an intense and structured training program, in order to operate correctly and reach and maintain the established quality standards.

At the manufacturing sites, the Quality Assurance department is responsible for the overall Quality System and deals with its implementation, while the Quality Control department performs analyses on each batch of a medicinal product, and on each of its components, before its release on the market. To ensure a full compliance with the company Quality System, the engagement of all the staff at all levels within the company is of paramount importance.

Another important aspect of the Quality System is the control and traceability of the supply chain. This includes all the players involved in the production and distribution of the components used for the manufacturing of the medicinal products, as well as those involved in their distribution, once they leave the manufacturing sites. (To know more on quality activities see Menarini Pills of Quality).

Periodical assessments of the Quality System are performed through internal audits, product quality reviews and evaluation of quality indicators by the Company’s senior management.

The ongoing digital transformation with the integration of advanced technology and digital systems is a challenge and an opportunity also for the Quality System Management. Acquisition of digital skills through trainings of the personnel is a prerequisite for the digital transformation. The use of digital technologies and data, as well their interconnection, will result in new activities or changes in the existing activities, as monitoring of process, controls and performance. The new manufacturing site’s design encompasses all the concepts of the digital transformation in technologies, process management, and people.

Menarini Pills Of Quality

HOW DOES MENARINI CREATE A DRUG

On average, it takes about 10 years of research and clinical development with the collection of data and information before reaching the moment in which we are certain of the drug’s effectiveness and submit it for approval to the health authorities in order to obtain the marketing authorisation. After this, the drug enters Menarini’s production cycle.

  1. Development 

    Development is the earliest stage of a medicinal product lifecycle. A meticulous scientific approach is applied to gain a comprehensive understanding of the product and manufacturing process in order to prove that the type of dosage form selected and the formulation proposed are suitable for the intended use. In this phase the safety and efficacy of a product are established through a series of pre-clinical and clinical studies, whose results are fundamental for the submission of the marketing authorization application to the competent Health Authorities.

    Read More
  2. Application for Marketing authorization 

    Marketing Authorizations are mandatory for the production and commercialization of medicinal products, whose application process is strictly regulated and it may differ according the geographic areas of submission.

    Information on quality, safety and efficacy are requested and critically reviewed by the Health Authorities that may ask for clarification or additional data. Therefore the whole process requires some time before the Authorities reach a conclusion.

    Only after the approval, the company makes a medicinal product available to patients.

  3. Production and Control 

    Production and Control are performed at the manufacturing sites authorized by the local Health Authorities, following the positive outcome of an inspection aimed to prove the compliance with the good manufacturing practice rules.

    Being Menarini an international Company, its manufacturing sites are inspected also by Health Authorities coming from all over the world.

    Procedures are in place to govern each step carried out at the site under the supervision of the Quality Assurance Departments.

  4. Distribution 

    Medicinal products have to be stored and transported according to the climatic conditions described in the Marketing Authorization in order to avoid any negative impact on their quality. Menarini has procedures in place to continuously monitor Temperature during the storage and the transport and to select suitable carriers, whose trucks are equipped with air conditioning system able to guarantee that the correct Temperature is maintained throughout the travel

  5. Product Maintenance 

    Maintenance involves the commercial phase of a product lifecycle, strengthening quality and resulting in a benefit for patients.

    It deals with a periodical quality review of the products, gathering all the necessary information to highlight trends and points which may require more attention or improvements. It deals also with the implementation of changes to a product by promoting innovation, with the application of new technologies.  






The process that leads to new medicines

PRECLINICAL DEVELOPMENT

PURPOSE
  • Mechanism of action of the experimental new drug
  • Non-clinical safety and efficacy profiles
  • Dosage form selection

CLINICAL DEVELOPMENT

PURPOSE
1
Phase 1: safety and dosage
2
Phase 2: efficacy and side effects
3
Phase 3: efficacy and monitoring of adverse reactions

MARKETING AUTHORIZATION

PURPOSE
  • Submission of the drug’s dossier to regulatory authorities
  • Release of marketing authorization
  • Product launch
up to 10 years
to create a new drug

Continuous Quality

MANUFACTURING AND QUALITY CONTROL
Over 1,000,000 tests and controls per year.

PHARMACOVIGILANCE, MENARINI IS LISTENING
Objective to monitor all input related to the use of our drugs around the world.

SCIENTIFIC INFORMATION
Menarini constantly provides physicians with scientific information.

Pharmaceuticals

Innovation & Research

We are highly committed to developing effective solutions to address the global threat associated with antimicrobial resistance. Discover more about our R&D projects in the anti-infectives area.

Read More