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quality comes first


Quality

The Quality is the pillar on which our Company relies and that guides all the activities during the development, production, distribution and pharmacovigilance phases, with the goal to assure the safety, efficacy and the patients appreciation of our pharmaceuticals.

To achieve and maintain high quality levels, a Quality System is operative and it defines requirements and internal rules which are appropriate to the activities complexity.

Any activity with an impact on pharmaceuticals quality is regulated by procedures containing the modality to perform all the activities which could have an impact on the product quality. All the personnel who perform activities related to the product quality (production, warehouse, quality control, quality assurance, engineering) are subjected to an intensive and structured training program, in order to be able to reach and maintain the agreed quality levels.

Within the production Sites, the Quality Assurance Department is responsible for the whole Quality System and for its correct application in each Department, while the Quality Control Department performs the analysis on each pharmaceutical lot and on each of its components prior to its release on the market. To assure a total compliance to the Company Quality System, it’s crucial to involve all the personnel, at all company levels. 

Another important Quality System aspect is the control and traceability of the logistic chain. This includes all the operators involved in the production and distribution of the components used for the pharmaceuticals manufacture, and also the ones involved in the distribution of the pharmaceuticals themselves, once they leave the production Sites. (to learn more about the activities related to Quality, please see Menarini Pills of Quality).

The Quality System, moreover than the already stated checks, is periodically evaluated through internal inspections, product quality audits and evaluations from the Company Board and Quality Key performance indicators.

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 interconnection between the digital technologies and data utilization will bring to a different management of the existing activities, like for the processes monitoring, controls and performances. The new Production Site design project encloses all the concepts of digital transformation, applying it not only to the technologies but also to the processes and personnel management.

Menarini Pills Of Quality

HOW DOES MENARINI CREATE A DRUG

On average, 10 years of Research and clinical Development with data and information collection are needed to prove the safety and effectiveness of a new drug. Only after these scientific evidences have been collected, we can submit the results to Health Authorities for approval in order to gain authorization to market introduction. Only after the release of this authorization, the drug enters the Menarini 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.

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  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 within the Production Sites which have been authorized by the National and Local Authorities, following the positive results of the periodic inspections which have the objective to evaluate the Sites compliance to the Good Manufacturing Practices.

    Being Menarini an International Company, its Production Sites are inspected by Health Authorities from all over the World.

    All the activities performed within the Sites are ruled by operative procedures with the Quality Assurance Department supervision.

  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, through new technologies application.  






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 Improvement

 

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.

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