The year of the coronavirus has brought us new practices and enabled a lot of good new things that might not have been experimented with in the absence of compulsion – or at least it would have taken much longer. Routines have been subjected to re-evaluation. This was also the case for the audits required by pharmaceutical companies, which we were, due to coronavirus restrictions, unable to organise the usual way in our logistics centres, say Quality Director Anni Svala and Quality Assurance Pharmacist Elina Rintala.
It is of paramount importance for us to ensure the continuity of the pharmaceutical supply chain as well as the health and well-being of our personnel. That is why we minimised all guest visits very early on in the pandemic. At the same time, it was important to ensure that our pharmaceutical customers receive good service and feel that we are performing well in the medicine distribution task they have outsourced to us. We always design a pre-tailored solution for the customer that enables us to arrange the annual GDP distributor audits appropriately while taking into account the regulatory requirements. Due to the changed situation, we started to build a joint auditing model in which an experienced third party auditor, well-known to the pharmaceutical sector, audits our operations on behalf of our customers. In addition, remote audits performed by pharmaceutical companies have become more common during the coronavirus year.
Customer-specific auditing agendas guide joint and remote auditing
During 2020, we arranged two joint audits, where pharmaceutical companies were able to participate. In the joint audit model, the pharmaceutical company creates an auditing agenda together with a third party. In addition to the actual audits, we have also arranged separate virtual meetings where customer-specific questions can be reviewed directly with our customer company.
- We wanted to build a cost-effective model for our customers that meets the legislative requirements while taking into account the customer's requirements and wishes. We hope that the joint auditing and remote auditing models will remain part of our normal practices even after the pandemic, says Quality Director Anni Svala.
Audits normally cover a wide range of aspects related to GDP (Good Distribution Practise). The most common aspects are supplier assessments, staff orientation and training programmes and aspects related to logistics.
- The auditing agenda is always a package compiled on the basis of the customer and the third party's risk assessment, and it aims to get the most comprehensive understanding of the appropriateness of our operations and our compliance with the requirements, says Quality Assurance Pharmacist Elina Rintala.
Creative solutions for warehouse tours
A tour of the warehouse and an inspection of the premises are integral parts of the auditing process. During joint audits, tours of the warehouse are possible if the auditor is well protected. In this situation, the third party acts as the customer's eyes and ears, conveying an objective situational picture to the customer. As for remote audits, we have streamed real-time footage from the warehouse to the customer. In the future, we wish to increase Tamro's capabilities in this area. We want to offer better virtual services that do not require our customers to be physically present.
The feedback we have received from our customers on remote and joint audits has been positive. When travel is omitted, the working hours spent on auditing become more cost-efficient and create savings. Even with the changes to the ways in which audits are carried out, it is still important to ensure that the basic idea of auditing remains the same. It is still a spot-check aimed at ensuring the conformity of the operator and the quality of the service. For the success of the audit, it is important that the auditor is a party independent of us, acting in accordance with the instructions and wishes given by the customer as well as complying with the legislative regulations.
At Tamro, we want to continue to be at the forefront of making our customers' everyday lives easier. The pandemic forced us to think about things from a new perspective. We also applied the same practice to inventories, which faced the same challenge due to visitor restrictions.
- Once the pandemic is over, we will of course welcome our customers as before, but we also hope that this new virtual model will work alongside as a viable option, Svala and Rintala conclude.