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 concerned about 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 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 management 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 quality assurance Group-wide organization ensuring a quality oversight of all activities. This organization comprising more than 100 employees and spread out over various Group sites, this organization 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 in compliance with and in anticipation of regulatory requirements that apply to the various research and production facilities, 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 effectively address all quality incidents inherent to the pharmaceutical business.
We have had an efficient regulatory monitoring system in place for several years, allowing it to stay abreast with 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 in a right first-time approach to reduce waste and destruction from manufacturing to commercialization. Right first time is deployed throughout the organization and is measured at the end customer.
Ratio of technical complaints per million units marketed
|OUR KEY OBJECTIVES|
Pre-development and development phase
We implement Good laboratory practice (GLP) relating in particular to data traceability, then select CROs working in accordance with these GLPs.
|> 100% of products subject to pharmaceutical registration are subject to verification for animal/human/environmental safety, quality, stability and efficacy|
Systematic qualification by our team of the materials purchased from suppliers (active ingredients, excipients, packaging) in terms of quality and reliability. When possible, several sources are identified 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 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 destruction of materials or finished products.
> 100% of products subject or not to pharmaceutical registration undergo component and raw material control at every manufacturing stage.
> 100% of Virbac industrial sites are certified.
> 100% of employees are trained in manufacturing processes.
For the transporting of drugs, we apply Good distribution practices (GDP), such as, for example, 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 diagrams and pictograms and appropriate communication media for an optimal understanding of information 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 or not they require pharmaceutical registration, and nutritional products that do not require pharmaceutical registration are subject to advice and support actions 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 qualified pharmacovigilance person (veterinarian) and an interim qualified person who compiles all the cases, analyses them, and decides whether or not these side effects are attributable to the use of the drug or food in question, and officially reporting these cases to the supervisory authorities when appropriate. Taking account of 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 or not they require pharmaceutical registration, and nutritional products that do not require pharmaceutical registration are subject to monitoring using the pharmacovigilance and nutrition vigilance mechanism.|
To ensure the efficacy over time of its pharmaceutical products that require registration, Virbac carries out ongoing research on their stability.
|> 100% of products requiring pharmaceutical registration are subject to ongoing stability studies|
Taking a collaborative approach to designing a quality benchmark that integrates standards for all production and research sites, in all departments and towards all subsidiaries, while taking into account the regulations and the diversity of product and dosage forms. The Virbac quality system (VQS) was then extended to integrate the Group’s organizations, processes, tools and Quality standards (core model),
We have more precise identification and updating of 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 and 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||0.66‰||0.71‰||0.38‰|
|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
No cases of non-compliance with voluntary codes and regulations posed any danger to the health of animals. No packaging non-compliance has had any consequences on the distribution of the products.