In our quest for continuous improvement, we attach paramount importance to the quality of our products and services in order to offer high standards to our stakeholders: veterinarians, farmers and pet owners. The demand for food is growing in the world, due to the population’s growth, which is increasingly concerned about its diet. Faced with this trend, we aim to work towards the constant improvement of food producing animal health in order to contribute to a global supply of better quality and more affordable meat and milk.
As far as companion animals are concerned, we are working hard to offer veterinarians and animal owners medicines, vaccines, health products and a range of foods adapted to the carnivorous diet (respecting the needs of animals) that help extend the life span 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.
OUR KEY OBJECTIVES
An organization dedicated to quality
To ensure proper application of good practices at various stages of the product life cycle, Virbac has rolled out a dedicated Group-wide organization that covers the topics of quality control and quality assurance. Comprising more than 100 employees and spread out over various Group sites, this organization implements the Group’s quality policy across three areas: product control, pharmaceutical compliance and sustainable economic performance.
The goal is to raise 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 enables us to detect, trace and efficiently process all quality incidents inherent to the pharmaceutical activity.
OUR POLICIES AND ACTION PLANS
In compliance with the regulations of each country, Virbac meets the highest applicable quality-security-efficiency standards required, particularly to obtain MA for its products. These standards cover every stage of the product life cycle, meaning before they are marketed and after they are placed on the market.
Through our product 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 throughout the manufacturing process.
KEY ACTIONS TAKEN BEFORE THE MARKETING PHASE
Pre-development and development phases
Virbac implements Good laboratory practices (GLP) relating in particular to data traceability and then selects CROs working in compliance with these GLP.
|> 100% of products subject to pharmaceutical registration are checked for animal/human/environmental safety, quality, stability and effectiveness.|
Purchasing and subcontracting
Our teams systematically assess the materials purchased from suppliers (active ingredients, excipients, packaging) in terms of quality and reliability. Whenever possible, they identify several sources to limit the risk of shortages and give preference to purchases from the leaders in pharmaceutical equipment. Finally, we outsource to subcontractors specialized by pharmaceutical form.
|> 100% of active ingredient suppliers are qualified and analyzed during certification.|
During the production phase, we implement Good manufacturing practices (GMP), applied in particular through the certification of all our industrial sites. Actions are also implemented at the level of the manufacturing line in order to ensure finished 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 testing at every manufacturing stage.
> 100% of Virbac manufacturing sites are certified.
> 100% of employees are trained in manufacturing processes.
For the transporting of drugs, we apply Good distribution practices (GDP), such as compliance with the cold chain when required by the nature of the products. With regard to the organization of transport according to the regulations for the transport of high-risk products, safety data sheets for raw materials and finished products are made available to the personnel as well as to the carriers. Dangerous goods are transported in packaging that meets applicable standards.
Packaging and promotion
The development or selection of specific packaging is determined on the basis of a product safety assessment. We strive to develop appropriate diagrams and pictograms and communication materials for an optimal understanding of the information essential to consumer health and safety.
For all promotional communications, Virbac respects the scientific and technical claims demonstrated during the product development stages. Finally, any product claim shall be scientifically substantiated and made available to regulatory agencies in accordance 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 supported with advice and guidance for the product users.|
KEY ACTIONS OCCURRING AFTER MARKET LAUNCH
In accordance with regulatory obligations, we monitor the safety and effectiveness of the pharmaceutical and nutritional products we place on the market. This is achieved through a dedicated organization comprising a qualified pharmacovigilance person (veterinarian) and an interim qualified person, who collects the cases, analyses them and decides whether or not these adverse reactions are attributable to the use of the medicinal product or food in question, and officially reports these cases to the regulatory authorities if necessary.
By taking into account the results of pharmacovigilance, Virbac is able to improve the knowledge of its products (e.g. by adding precautions for use) and thus make 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 nutrivigilance system.|
Continuous stability studies
To ensure the sustained effectiveness 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.|
Virbac has had an efficient regulatory monitoring system in place for several years, allowing it to stay abreast of regulatory developments. This monitoring system is carried out through inter-professional organizations:
|> 100% of products, whether or not they require pharmaceutical registration, and nutritional products that do not require pharmaceutical registration are subject to regulatory monitoring.|
Key actions related to the Group’s quality strategy
The quality benchmark was designed on a collaborative basis that integrates standards for all production and research facilities, in all departments and all subsidiaries, while taking into account regulations and the diversity of products and dosage forms. The Virbac quality system (VQS) was then extended to include the Group’s organizations, processes, tools and quality standards repository (core model).
We have identified and updated more precisely 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), focused on delivering products on time and with the expected level of quality to meet our customers’ expectations.
|> The Group quality benchmark was built and shared with 100% of the R&D centers and production sites.|
|Number of non-compliances:||out of 8,333 product references:||out of 8,688 product references:|
|° regulations and voluntary codes||16||25|
There were no cases of non-compliance with regulations and voluntary codes that posed a danger to animal health. There were no packaging non-conformities that affected the distribution of the products.