We’ve asked Laura Masini, QA of CSV Active, what the value of quality for CSV Active is. So, she told us how the Quality Unit of CSV Active works.
CSV Active staff working in the intermediates and API trading business has for many years been linked to suppliers mainly form the Far East thus assuring costumers of a highly qualified knowledge and meeting all their technical and regulatory requirements. Today, CSV Active works mainly in Europe and especially in the Italian market.
The focus on quality started about 8 years ago, as Laura told us. Indeed, “in 2014 AIFA issued a legislative decree whereby the importation was defined as production activity. CSV Active decided then to kick off the route to become a Pharmaceutical Workshop. In the next three years, we set up a document management system, starting with procedures defining in detail all quality-related aspects, such as the management of documentation, of deviations and corrective actions or the way suppliers are selected and qualified.”
For this reason, CSV Active has established a new office, which can be called Quality Unit, currently consisting of Laura, which is the Quality Assurance, and Tommy Barzetti, CSV Active QP, i.e. the qualified person. Laura explained us that “these are two compulsory figures in the relationship with AIFA. The QP must certify the batch release and is a reference figure responsible for guaranteeing the supply chain and the qualification of ours suppliers, while the QA is responsible for the entire quality management system within the pharmaceutical workshop.”
Then she specified the process to obtain import approval for an active ingredient, a process that involves specifically the quality department. “The first step for the approval consist in the audit. This GMP inspection is a key activity and is a part of the qualification process of our internal procedures. Both the QP and I are qualified and authorized to conduct audits. For this kind of activities, our previous working experience in the active ingredients production has turned out to be essential since we are trained to notice and deal with any problematic related to the pharmaceutical bulk production.”
Experience and ongoing training.
But quality involves also ongoing training for the staff. As Laura said, “preparing an annual training plan and implementing these training activities are very important to us in CSV Active. especially because Being a Pharmaceutical Workshop means that CSV Active has to maintain a certain level of knowledge and internal organisation. All our employees are periodically trained about GMP standards and therefore all our staff is constantly oriented towards quality aspects. And of course this is a benefit for the end customers too, as knowing they’re dealing with a counterpart who is competent and knows all the requirements to be met certainly makes our interlocutors feel more comfortable. This applies to the Quality Unit, which by its very nature is always up-to-date and informed, but also to the sales function. CSV Active sales staff, for example, is able to assess from the very beginning whether or not a specific producer meets the basic requirements and whether or not he is a candidate for a subsequent selection phase, thanks to the training.”
The power of the Group.
“Thanks to our belonging to CSV Life Science Group” Laura said, “in CSV Active we’re always putting in the middle the service quality for the client. Advantages for whoever decides to work with us are several, starting from the audits that in addition to be an obligation for a Pharmaceutical Workshop are a plus for the customer itself. Indeed, all the active ingredients producers are obliged like CSV Active to be inspected every three years. But, our customers can rely and refer directly to us, since we have always a complete package of documentation. For example, recently one of our business partners who was upgrading its regulatory department asked us if we could share our audit report and the management and closure of deviations.”
A plus for suppliers too.
We’ve asked Laura if suppliers also have an advantage in cooperating with CSV Active. “Of course they have a benefit” she replied. “Actually, for our suppliers we are not only a business partner that conducts audits, defines all the documents and aspects for the authorization, but we are always responsible for maintaining their qualification status, creating a continuous exchange that improves and reinforces their performance.
Moreover, we help the suppliers understand what the regulatory requirements in Italy and Europe are. For instance, an Indian company was struggling after an Italian producer asked them additional documents. They were at firs reluctant and did not understand the client needs, who wanted the documentation in order to comply with Italian regulations. But, again, we succeeded in managing customer needs, Italian regulations, and the concerns of the Indian supplier who, having understood the problem, decided to share the documents. We can therefore say that CSV Active is like an intermediary between the Italian and European regulatory expectations, and then the following client needs, and the third countries legislation. This allows us to enrich the supplier with all the information related to Italian laws and to understand the critical points in the interactions between suppliers and customers.”
