Three-dimensional quality concept in a veterinary pharmaceutical company

When you work as a Quality Director in a pharmaceutical company, you have to get in touch with both your inner eagle and curling team member, keeping your eyes and ears open, eyes on the prize, and reflexes sharp. When everyday work runs smoothly, we concentrate on keeping the path of the product clear all the way to the desired goal, as if we were playing curling in the Olympics.

In my work, I often look at quality from three different perspectives: products, processes and people. While product-related quality management requires reporting, processes and people require time, dialogue and problem-solving skills.

Aiming for high-quality products

When it comes to products, quality is relatively easy to measure. Pure ingredients and agreed manufacturing methods guarantee high-quality products, and annual quality audits of partner factories help with quality control.

Product-related quality management may also involve a great deal of reporting. For example, when applying for marketing authorisation, we must be able to convince the authorities of the fact that our product is of such high quality that it deserves marketing authorisation. We draw up thousands of pages of reports indicating who manufactures what and when, why the medicinal product should be put on the market, and how we have prepared for unexpected matters.

Contract manufacturers and partners play a significant role in all the phases of the process. It’s the task of the quality unit to make sure that the product can be manufactured at the exact quality level agreed upon with the authorities. We stay in close contact with our partners and carry out various inspections and make reporting requests to our contract manufacturers. With a good partner, things run smoothly and any questions or problems are addressed immediately.

Processes in order

Since, in addition to holding the marketing authorisation, Vetcare also acts as a pharmaceutical wholesaler, we practise the recall of medicines on an annual basis. How would we act in the case of problems, do our partners react sufficiently quickly, and how do we ensure continuous patient safety? What do we do if leaking medicine bottles are found in Australia or the wrong expiration date is printed on the packaging?

The recall exercises help our team develop our internal and external processes and check the response times of our partners. Often the debriefing following the exercises is rewarding for the team, and the exercises also help us learn many good lessons.

As a pharmaceutical wholesaler and market authorisation holder, it is our responsibility to ensure the availability of the medicines we provide, to prevent patient safety from being compromised.

People as a competitive advantage

The modern network-based operating model requires that all members of the value chain have the same notion of high quality. One medicine requires the input of the manufacturer of the chemical element and active pharmaceutical ingredient, packaging and logistics teams, the marketing authorisation holder, the marketing team, distributors and veterinarians, among others. That’s why it’s important that we all have the same view of what we are doing and what it takes, for example, in terms of the processing and storage of products, to maintain high quality. 

Finding suitable contract manufacturers is also a mountain we need to climb. Even though the veterinary medicine industry is constantly growing, it is still much smaller than the pharmaceutical industry, and there are not that many factories specialised in veterinary medicinal products in the world.

From the point of view of security of supply, there should be at least two factories manufacturing the product. However, in reality, finding one may already prove challenging.

In other words, quality has to do with all the functions from the laboratory to the veterinarian’s bag or home pharmacy. Collaboration and fluent dialogue between partners and different operators help compile the perfect package.

Focus on the quality of medicines and the wellbeing of animals.

Ahead by a snout, Mirva

Writer: Mirva Teronen acts as the Director of Quality at Vetcare and is responsible for the company’s global quality initiatives and activities

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