Challenges for QP: imports of medicines, vaccines and new technologies


As the previous years, AFI decided to collect the most interesting topics and the main challenges for QP, in its annual meeting, in order to take stock of the situation of the past year and to look with excitement at 2022. In the first part of the second day of the event, attention was paid on imports of medicines, vaccines and new technologies. Vittorio Tonus, QA director in Merck, and Massimo Cavalieri, founder of Euraconsult, are the appointees to moderate the discussion.

Imports of medicines: Roche experience

Can a single company experience teach to the others? This is the question that guides Luca Perani intervention, QP in Roche, who will present his experience about the flow of imports of medicines from abroad.

Imports goes on even during pandemic

QP Perani speaks about Roche’s need to import drugs from abroad in order to face the deficiency during pandemic. The company decided to approach this delicate situation in close cooperation with AIFA. The preventive deal about the paperwork needed has brought some advantages. AIFA could produce a single, complete document valid for more than one import instances and, in the same way, QP had to design one single equivalent paper for the imported product. This reduction has lightened the workload for both actors and speed up the whole import process.

Could a capable of bringing advantages problem management be applied, in a structured way, even in a period far from the emergency?

Flu vaccines unavailability

Perani continues telling how his company could transform a disadvantaging situation, such as the lack of a flu vaccine, into a chance to start a virtuous cooperation with AIFA. Thanks to the ministerial suggestion of involving competent physicians, the problem could be solved and, once identified the right foreign distribution company, it was possibile to keep on importing and administrating.

That was example of an effective flow of imports that could be useful even to different sectors from the pharmaceutical one.

The prospective case

In the end, Perani makes a reflection in prospective about act 326/2003. The legislation establishes an AIFA fund of 5% for the import of medicines destined to compassionate use, but it has momentary been suspended until a next revision, in order to simplify the act. Roche made a proposal for the entry of companies in the supply flow. It should increase the process speed, fundamental parameter, especially when dealing with compassionate care.

A synergy between AIFA and companies is desired by Domenico Di Giorgio too, coordinator executive of the inspection area and AIFA authorization. Indeed, old regulations review is not an advantage for companies only, but even for ministerial authority and, after all, for patients too.

A QP trip through new technologies

Alberto Bartolini, member of the AFI and QP Council of Presidence of CIT srl, addresses the topic of new technologies as a challenge for QP. If we think about remote working, meetings, technical assistance, audit: smart-working mode has revolutionized this sector. This change concerns business processes, which have to be continuously reviewed to fit with new demands, but even the cultural approach. From the passive and obliged acceptance of the change it is necessary to go toward a welcoming vision that accepts it as a winning strategy to keep the competition alive.

From this point of view we cannot miss talking about serialization. It is a complex complex which got into trouble many companies and that A. Bartolini resumes in few steps, starting from the production site. Here, many softwares and devices linked to equipment interact with the cloud, where serial numbers are generated and preserved. Then, the entire process is controlled from the top, from national and European databanks.

Cold chain management can get benefits too from these new technologies. A central virtual platform in cloud could integrate with local systems and communicate with reading devices and with RFID technology. Connection with the platform allows to stakeholders to monitor the trend of their products, with the guarantee of a data protection, thanks to blockchain technology, which is able to integrate itself to the system.

Lastly, the process of lot releasing has gone toward a serious digitalization. From a past time where it was all paper, to a present tense made of several digital systems, such as LIMS, until a future into which systems integration will get the lot release by means of digital signature. It will show great benefits in terms of efficiency and quality.

Challenges and opportunities for QP on vaccines

Cecilia Lombardi’s long experience in multinational scope and her current role of UE GMP and regulatory compliance director in ThermoFisher makes her the perfect speaker for the vaccines production theme. To ThermoFisher company it means to review every aspect their production and distribution processes, to adapt them to the need for such a delicate product, with restrictive manipulation and conservation requirements. The investment in new facilities has been remarkable, as it has been the one of the construction of a new departement in the establishment, which could allow to design an optimised flow for the new production.

Starting a new production

Procedures reviewing lead to the arrangement of the analysis of a double set of samples of active ingredients. As far as preparation and storage procedures, it has been necessary to implement thermic mappings and environmental controls. However, the main issue when starting a new production is the process of staff training, as Lombardi claimed. New systems and new installations need for the learning of new skills. With that purpose, the company exploited tool such as virtual reality and augmented reality, with an increase in the training effectiveness and efficiency.

The management of the challenging vaccines cold chain has been led by opening the lots packaging and working on single pallets of product. In this way, waiting times can be reduced, and the temperature can be maintained. Finally, a visual inspection optimization allowed to reduce waste. How about the analytic aspect? Cooperations with external labs and universities guaranteed to dispose of all the skills needed.

Lastly, C. Lombardi examines the topic of the ministerial authorizations needed to conduct these new activities. One more time the synergy created between company and AIFA allowed to stay on schedule.  With the help of the cooperation between companies functions and a new approach, especially cultural.