ENSURING THE QUALITY OF PRODUCTS AND SERVICES

CHALLENGE

As an animal health stakeholder, Virbac designs, manufactures and sells veterinary medicines, vaccines, and general health products to prevent disease and improve animal well-being and health. The quality of products and services is essential in the eyes of stakeholders, who are veterinarians, farmers and animal owners.
- The societal challenge related to the health of food producing animals is to contribute to a worldwide supply of meat and milk that is more abundant, of higher quality and less expensive. The goal is to meet the steadily increasing quantitative and qualitative food demands of a fast-growing global population that wants to eat better.
- The challenge related to companion animals is to offer veterinarians and animal owners medicines, vaccines, health products and a petfood range tailored to carnivores (in keeping with the animals’ needs) and that prolong the lives 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.

STRATEGY

In order to meet these major challenges, Virbac has defined a strategy aimed at ensuring the quality of its products and services, improving the quality of life and health of animals while ensuring the comfort and safety of those who administer these products: veterinarians, farmers and animal owners. This strategy is based on two tenets; first, attaining an irreproachable level of regulatory compliance as a policy principle at every stage in the manufacturing of our products, and secondly, a monitoring and quality assurance body that ensures proper application of this policy principle on Group sites as well as those of strategic partners.

RISKS

The key risk associated with this challenge would be producing medicines or vaccines of inadequate pharmaceutical quality, which could have negative effects on the health of animals and, in turn, on humans. For more information on the risks associated with this CSR challenge, please refer to the chapter on risk factors page 61 (risks related to product compliance and risks related to product liability).

To reduce exposure to this risk, and in compliance with the regulations of each country, Virbac meets the highest applicable quality-safety-efficacy standards, particularly essential for the purpose of obtaining a Marketing authorization (MA) for products. These standards involve every stage in the product life cycle, meaning before they are marketed and after they are placed on the market.
The Group’s key commitments aim at maintaining a high level of product and service quality through a “right first time” approach to reducing waste and destruction throughout the manufacturing process.

Assessment throughout the product life cycle

KEY ACTIONS PRIOR TO THE MARKETING PHASE

Pre-development and development phases

  • Implementation of Good laboratory practices (GLP) relative among others to data traceability.
  • Selection of the CRO (contract research organization) working in compliance with these GLPs.
    • 100% of products subject to pharmaceutical registration are checked for animal/human/ environmental safety, quality, stability and efficacy.

Purchasing and sub-contracting

  • Systematic qualification of materials purchased from suppliers (active ingredients, excipients, packaging) in terms of quality and reliability.
  • When possible, several sources are qualified to limit the risk of disruptions in supply, and preference is given to purchases from leading pharmaceutical suppliers.
  • Outsourcing to specialized subcontractors based on pharmaceutical form.
    • 100% of active ingredient suppliers are qualified and analyzed during certification.

Production phase

  • Implementation of Good manufacturing practices (GMP) 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 from 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.

Distribution phase

  • For the transporting of drugs, Virbac uses Good distribution practices (GDP), such as compliance with the cold chain, when required by the nature of the products.
  • Organization of transportation in accordance with regulations governing the shipping of high-risk products (availability of safety data sheets for “raw materials” and “finished products” to staff and carriers, packaging of hazardous products in packaging that meets current standards, etc.).

Packaging and Promotion

  • The development or selection of specific packaging is determined on the basis of a product safety assessment.
  • The development of diagrams and pictograms and communication media that provide a clear understanding of information fundamental to consumer health and safety.
  • All promotional communications: Virbac respects scientific and technical claims demonstrated during the product’s development stages.
  • Any product claims are 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 guidance from users of our products.

KEY ACTIONS OCCURRING AFTER MARKET LAUNCH

Pharmacovigilance
Virbac monitors what happens to those veterinary medicines it places on the market in terms of safety and efficacy in accordance with related regulatory obligations:

  • a dedicated organization comprising a qualified person in (veterinary) pharmacovigilance and an interim qualified person, who compiles all of the cases, analyses them, and decides whether the side effects are attributable or not to the use of the drug in question, officially reporting these cases to the supervisory authorities when appropriate.
  • the pharmacovigilance outcomes allow Virbac to develop 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 pharmaco/nutri vigilance process.

Ongoing stability study
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.

Regulatory monitoring
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:

  • at national level with SIMV in France, NOAH in the United Kingdom, BfT in Germany, etc.;
  • at regional level with IFAH-Europe, AHI in the United States;
  • at worldwide level with HealthforAnimals.
    • 100% of products, whether or not they require pharmaceutical registration, and nutritional products that do not require pharmaceutical registration are subject to regulatory monitoring.

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 based on three areas of focus: product mastery, 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. In addition, this Virbac quality system allows the company to efficiently detect, trace and effectively address all quality incidents inherent to the pharmaceutical business.

KEY ACTIONS RELATED TO THE GROUP’S QUALITY STRATEGY

  • Taking a collaborative approach to designing a Quality benchmark that integrates standards for all production and research facilities, in all departments and all subsidiaries while taking into account regulations and product and galenic forms varieties.
  • expansion of the Virbac Quality System (VQS), which presently includes the Group’s organizations, processes, tools and Quality standards (core model).
  • 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.
  • deployment of 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 repository was built and shared with 100% of the R&D centers and production sites.

AIMS & INDICATORS

Securing reliable information on product quality and use

Non-compliance with regulation and voluntary codes
In 2018, out of a total of 8,333 products marketed worldwide, Virbac declared or was informed by the national authorities of 16 cases of non-compliance observed in the field. None of these cases posed any danger to animal health.
In 2017, this non-compliance number was 78 out of a total of 8,376 products marketed worldwide.

Non-compliance related to packaging
In 2018, out of a total of 8,333 product references marketed worldwide, Virbac declared or was informed by the national authorities of 8 cases of packaging non-compliance, which had no impact on product distribution.
In 2017, this non-compliance number was 21 out of a total of 8,376 product references marketed worldwide.

Non-compliance related to promotion
In 2018, out of a total of 8,333 product references marketed worldwide, Virbac declared or was informed by the national authorities of 3 communications that did not comply with regulations and codes relating to promotional marketing.
In 2017, this non-compliance number was 6 out of a total of 8,376 product references marketed worldwide.

Training employees in all manufacturing process positions

100% of employees trained.

Supporting roll-out of the Group Quality referential at all sites

100% of sites supported.