A truckload of papers on the quality director's desk
In the pharmaceutical industry, everything comes down to quality. From the incoming raw materials, manufacturing, reporting, the distribution & transportation, and essentially all processes are under the scrutiny of the Quality Department from start to finish. As the Director of Quality at Vetcare, my job is to act as the foster parent for each and every product, whether it is a pharmaceutical medicine of over- the-counter product. From beginning to end, Quality is involved. Quality is there for the medicine all the way from the laboratory to the customer, nurturing, monitoring and reporting its development like that of our own child.
When everything goes well, quality is an inconspicuous part of the overall process. However, when the problems arise, we run around the office like headless chickens with our phones constantly going off.
The Quality Director’s journal mountain
The road from finding an original molecule to selling a complete product is long and fraught with risks. It is said that the development of a new medicine takes, on average, 10–15 years and can cost millions of euros a year. Even though the marketing authorisation applications required for each medicine would fill a lorry, commercial success is never guaranteed.
Quality documents do, in fact, capture the entire life cycle of a medicine, from the laboratory to commercialisation and to the pharmacy shelf or veterinarian’s bag.
Even though original molecules are analysed diligently and discovered often, only a fraction of them are commercialised into a product. The prerequisite for obtaining marketing authorisation is that the benefits of the product outweigh the disadvantages and that there is genuine demand and need for the medicine. I often compare the role of quality to that of a business partner: while we take care of official requirements, we innovate new things, help develop better and better products, and get them to the market even more effectively.
The world situation rocks the desk
In recent years, the work we do here in the Quality has been affected by various major issues. In addition to the pandemic and the war, the Olympics, a strike at UPM, and logistics challenges related to shipping containers have led to availability problems. It isn’t of much use that medicine bottles are ready if the products cannot be sent forward due to a lack of the right types of labels or cap seals.
If necessary, at times like those, we grab our phones and make calls to printing companies around to world to find the right kinds of labels or a printer suitable for data matrix printing.
In my line of work, days may take sudden turns, and the items on the to-do list may need to be reprioritised at a moment’s notice. It takes ingenuity and perseverance when shipping containers are in the wrong country or packaging materials are missing. Often afterwards, when everything has fallen into place, all that fuss seems kind of funny.
When the going gets tough, it helps to think about the social significance of the work. For example, in the past, it was no easy feat deciding whether or not give an anaesthetic to a dog, as the risks of the procedure had to be weighed carefully. New pharmaceutical innovations help us launch gentler medicinal products that are proven to be more effective and have milder side effects. That’s when you know you’re on the right path.
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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