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Sustainability

SustainabilityPeople's health: Recordati's priority since the beginningProduct quality and safety


In order to guarantee the highest possible levels of health and safety for patients, the Group is committed to guaranteeing product quality and safety throughout the Recordati supply chain, from the research and development phase for new products to the procurement of raw materials and the production and commercialisation of registered medicines.

During the research phase, specific clinical studies are carried out in order to ensure the efficacy and safety of the products and confirm the absence of any possible dangerous side effects. Furthermore, the results of these studies are assessed by regulatory bodies in Italy, Europe and all of the other countries around the world, before authorisation is given to introduce the medicines on the market.

Throughout the supply chain, our suppliers are selected and regularly assessed according to audit schedules in order to verify compliance with multiple criteria, from environmental factors to the quality of the ingredients. During manufacture, all medicinal products are produced in accordance with Good Manufacturing Practices in plants authorised by the relative local and non-European regulatory bodies. Our plants are constantly subject to inspections and checks to ascertain compliance with current legislation and internal regulations. 

The production phase involves strict and rigorous control of all raw materials and packaging materials used in the manufacturing and packaging processes performed by the Quality-Control laboratories of production plants or by third-party laboratories. In both cases, the Quality-Control laboratories must be expressly authorised and certified, with inspections performed by national and international regulatory agencies, in order to perform these control activities. Specifically, every batch of materials received from suppliers undergoes a quality-control procedure which impedes its use until the batch has been demonstrated to be fully compliant with the defined specifications that guarantee the quality and safety of the resulting pharmaceutical process.

Furthermore, all production processes employed are validated, demonstrating their capacity to provide reproducible finished products that are compliant with the quality, safety and efficacy requirements defined in product registration processes. Validation of production processes is guaranteed through the use of certified equipment subject to periodic recalibration, specially and periodically trained personnel, and rigorous standard operating procedures, with the goal of making every production operation and control reproducible and aligned with the defined standards.

For the product-commercialisation phase, the Recordati group has implemented a system aimed at guaranteeing compliance with European, Russian, Turkish and US Directives, and those of other countries with equivalent regulations in force, regarding anti-counterfeiting, observing the measures expected by the respective authorities with regard to product serialisation and aggregation, and for the use of quality seals on packaging, always in line with applicable local legislation. Furthermore, when handling all complaints made regarding its products, the Group investigates any possibility of counterfeiting.

Finally, the Recordati group operates a post-sale pharmacovigilance policy, enabling doctors and patients to promptly notify the Group of any significant events or adverse reactions experienced during the use of Recordati medicines.

Additional information can be found in the Consolidated Non – Financial Statement

Audits and inspections

In order to ensure the quality and safety of its products and verify the compliance of its suppliers with quality, environmental, health and safety legislation and regulations, the policies implemented by the Recordati group include periodic audits, as well as continuous inspections performed by the competent regulatory authorities and self-inspections within its own production plants.

Production plant inspections and audits 

The production plants of the Recordati group are regularly audited, both internally and externally by companies which are customers of the Group, or subject to inspections performed by the competent authorities, in order to verify compliance with product quality regulations.

During the production phase, every single batch of Recordati medicines is produced in accordance with the dossiers approved by the relative health authorities and is subject to controls designed to ensure their quality. 

Within its own pharmaceutical plants, the Group is committed to maintaining a quality control system that fulfils all national and international requirements, guidelines and standards for the production of finished pharmaceutical products, medical devices and dietary supplements. In particular, the manufacturing plants operate in line with GMPs (Good Manufacturing Practices) and are regularly verified through inspections conducted by the competent national and international authorities. The Quality Control departments are responsible for the control of procured raw materials and the finished products in accordance with the relative procedures, approved methods and the pharmacopoeial monographs.

In 2020, a total of 98 inspections/audits were carried out at the Group’s pharmaceutical production plants in order to assess product quality and safety. Of these, 66 (67%) were self-inspections carried out by the Group at its own plants, while the remaining 32 (33%) were carried out by the competent authorities (Health Ministries, Agencies, Certification Bodies, FDA and AIFA) and third-party companies.

Subdivision of quality and safety inspections/audits at pharmaceutical plants

All of the inspections resulted in renewal of the existing authorisations.

In addition to the inspections received from external bodies starting in 2019, the pharmaceutical production plants are subject to internal audits carried out by the Group's internal Quality Assurance unit on an annual basis.

Regarding inspections in chemical and pharmaceutical plants, it is noted that the Italian plant in Campoverde di Aprilia underwent 12 internal audits of production, quality and maintenance units performed by the Quality Assurance unit and 8 audits by customers.

Supplier audits

One of the main control measures implemented in the supply chain are the audits carried out by the Group at third-party companies which produce medicines, medical devices and dietary supplements, as well as suppliers of APIs, excipients, packaging and services. In addition to assessments at the supplier approval stage, use of suppliers is also dependent on the ongoing quality monitoring of all supplies in order to constantly verify the level of quality and compliance with agreed specifications.

In line with the current procedures for approval, all suppliers, particularly those supplying active substances, excipients, packaging materials and services, are subject to periodic audits as defined by a risk assessment. In fact, in 2020 the Pharmaceutical Division of the Recordati group conducted 94 supplier audits, of which 28% on third-party manufacturers, 22% on suppliers of active substances, 16% on suppliers of packaging, 23% on service suppliers and 11% on suppliers of excipients.

Subdivision of supplier audits conducted by the pharmaceutical division by product category

Regarding supplier inspections carried out by the chemical and pharmaceutical division, it should be noted that during 2020 the Italian Campoverde di Aprilia plant conducted six audits of suppliers of raw materials and services.



Anti-counterfeiting​

Recordati operates in compliance with anti-counterfeiting legislation and takes all the necessary steps to allow the unique identification of medicinal products, as required by the law regarding serialisation in pharmaceutical manufacturing.

Since 2006, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has been developing a standardised medicinal products traceability system as part of the fight against counterfeiting. Working in collaboration with three other European organisations, EFPIA has been involved in the creation of an ambitious coding and serialisation system known as the European Stakeholder Model (ESM). In conjunction with this project, ESM members worked to implement the European Medicines Verification System (EMVS) which aims to regulate the dispensation of medicines to ensure product authenticity. 

In this context, in February 2016 the European Parliament issued a regulation dictating the technical requirements for all prescription medicines in order to combat medicines being counterfeited. This regulation came into force in February 2019. However, certain member states, Italy included, are exempt from implementing this regulation for a further six years due to the adoption of internal anti-counterfeiting systems at national level. From such date, medicinal products that do not comply with the safety requirements established by this regulation may no longer be marketed. 

In this regard, in 2015 the Recordati group launched a project to ensure that all medicinal products produced at its own production plants or those of third-party companies comply with this regulation. The project was completed in line with the implementation deadlines provided for by legislation and the packs produced for the Group have been compliant with legislative requirements since January 2019. All information generated in regard to the serialisation of individual packs are collated in a database designed to enable the in-out management of all third parties of the Group as part of a European data-collection system.

Similar initiatives aimed at combating the counterfeiting of medicinal products have been launched or are currently being implemented in various countries in which the Group operates. Specifically, in Turkey, China, the US, Korea and Russia, drugs marketed by the Recordati group are already fully aligned with these safety requirements. In Brazil, where a drug anti-counterfeiting directive has recently been issued, implementation of similar regulation is planned within the coming years. For this reason, Recordati has launched a new project to allow provision of drugs compliant with these requirements by the deadlines defined for all products marketed by the Group in this country.