In the pursuit of continuous improvement, we place great importance on the quality of our products and services to offer high standards to our stakeholders: veterinarians, farmers and animal owners. The demand for food is increasing worldwide, due to the growing population, which is increasingly mindful of its diet. In the face of this trend, our ambition is to work towards the constant improvement of the health of livestock animals to contribute to a global supply of better quality meat and milk at a lower cost.
Regarding companion animals, we are mobilizing to offer veterinarians and animal owners medicines, vaccines, health products and a range of foods that are tailored to a carnivorous diet (in keeping with the animals’ needs) and make it possible to prolong the lifespan of animals and improve their quality of life. This in turn contributes to the improved well-being of the owners and is of particular benefit to people who live alone.
A GROUP QUALITY POLICY
Our quality policy is the commitment of the Group executive committee to mobilize each employee to strengthen the quality culture in our daily activities. It applies to all sites, subsidiaries, subcontractors and suppliers.
The strategy aims to control our activities, comply with current regulations and improve our performance:
|OUR KEY OBJECTIVES|
An organization dedicated to quality
In order to ensure proper application of best practices at various stages of the product life cycle, we have deployed a dedicated Group-wide organization that covers the topics of quality control and quality assurance. This organization, comprising more than 100 employees and spread out over various Group sites, implements the Group’s quality policy based on three areas of focus: product control, pharmaceutical compliance and sustainable economic output. The goal is to elevate the quality standards to comply with and anticipate the regulatory requirements that apply to the various research and production sites, as well as the commercial subsidiaries, and to ensure the Group’s sustainability. At the same time, this quality system allows us to efficiently detect, trace and address all quality incidents inherent in the pharmaceutical business.
We have had an efficient regulatory monitoring system in place for several years, enabling us to stay abreast of regulatory developments applicable to all of our ranges. This monitoring system is carried out through inter-professional organizations:
In compliance with the regulations of each country, we meet the highest quality-safety-effectiveness standards applicable. These standards involve every stage in the product life cycle, meaning before they are marketed and after they are placed on the market.
Through our quality policy, we are committed to maintaining a high level of product and service quality with a right first time approach, enabling us to reduce waste and damage throughout the manufacturing process until placement on the market. Right first time is deployed throughout the organization and is measured at the end customer.
In 2022, we remained below the five complaints per million units sold. The number increased slightly due to the increased attention paid to customers (incentive to report information) in order to accurately collect the points of improvement for each product.
|Ratio of technical complaints per million units marketed||4.4||4.0||4.6|
|OUR KEY OBJECTIVES|
Pre-development and development phase
We implement Good laboratory practices (GLPs) relating in particular to data traceability, then select the CROs working in accordance with these GLPs.
|> 100% of products subject to Marketing authorization (MA) are subject to verification for Animal/Human/Environmental safety, quality, stability and efficacy.|
Our teams systematically qualify the materials purchased from suppliers (active ingredients, excipients, packaging) in terms of quality and reliability. When possible, they identify several sources to limit the risk of disruptions and prioritize purchases from leaders in pharmaceutical equipment. Finally, we use outsourcing from subcontractors specialized by pharmaceutical form.
|> 100% of active ingredient suppliers are qualified and analyzed during certification.
During the production phase, we implement current Good manufacturing practices (cGMP) that are applied through the certification of all of our manufacturing sites. Actions are also implemented at the production tool level in order to ensure end-of-production-line product quality that is in compliance from the start, thus limiting scrap or damage of materials or finished products.
> 100% of products, whether subject to Marketing authorization or not, undergo component and raw material control at every manufacturing stage.
> 100% f Virbac industrial sites are certified.
> 100% of employees are trained in manufacturing processes.
For the transporting of medicines, we apply Good distribution practices (GDPs), such as compliance with the cold chain, when required by the nature of the products. Regarding the organization of transportation in accordance with regulations governing the shipping of high-risk products, safety data sheets for raw materials and finished products are made available to staff and carriers. Hazardous products are transported in packaging that meets current standards.
The development or selection of specific packaging is determined on the basis of a product safety assessment. We strive to develop diagrams and pictograms and appropriate communication media for an optimal understanding of information that is fundamental to consumer health and safety. For all promotional communications, Virbac complies with the scientific and technical claims demonstrated during the development stage of the product. Finally, any product claim is scientifically demonstrated and made available to regulatory agencies in compliance with the requirements defined by national or supranational veterinary pharmaceutical agencies.
|> 100% of products, whether subject to Marketing authorization or not, and nutritional products that do not require Marketing authorization are subject to advisory and support measures for the product users.|
In accordance with regulatory requirements, we monitor the future of pharmaceutical and nutritional products that we market in terms of safety and efficacy. This is thanks to a dedicated organization comprising a person qualified in pharmacovigilance (veterinarian) and a qualified interim person, who compile all the cases, analyze them, and decide whether or not these adverse effects are attributable to the use of the medicine or food in question, and officially report these cases to the supervisory authorities when appropriate. Taking into account the pharmacovigilance outcomes allows Virbac to improve knowledge of its products (for example: the addition of precautions for use), thus making their use safer.
|> 100% of products, whether subject to Marketing authorization or not, and nutritional products that do not require Marketing authorization are subject to monitoring using the pharmacovigilance and nutrivigilance mechanism.|
To ensure the efficacy over time of its pharmaceutical products that require Marketing authorization, Virbac carries out ongoing research on their stability.
|> 100% of products requiring pharmaceutical registration are subject to ongoing stability studies..|
The Quality benchmark was designed on a collaborative basis that integrates standards for all production and research sites, in all departments and toward all subsidiaries, while taking into account the regulations and the diversity of products and formulations. The Virbac quality system (VQS) was then expanded to integrate the Group’s organizations, processes, tools and Group quality standards (core model).
We have more precisely identified and updated the skills required, acquired and to be developed, so as to provide suitable training plans designed to enhance team skills and embrace a pharmaceutical culture. Finally, we have deployed a multidisciplinary team (Research & Development, Production and Quality Assurance), aligned to deliver products on time and with the expected level of quality to satisfy our customers’ expectations.
|> The Group Quality benchmark was built and shared with 100% of the R&D centers and production sites.|
|Rate of batch recalls per 1,000 batches marketed||0.38‰||0.48‰||0.42‰|
|Rate of non-compliance with regulations and
voluntary codes for 1,000 batches marketed
|Rate of labeling non-conformities
per 1,000 product references
|Rate of promotional non-conformities
per 1,000 product references
The rate of non-compliance with regulations and voluntary codes increased slightly following more reports due to the extension of the scope of escalation asked by the European authorities. No cases of non-compliance with regulations and voluntary codes posed any danger to the health of animals. No packaging non-compliance has had any consequences on the distribution of the products.