Making Pharmaceuticals, one of the main events in the pharmaceutical sector, was held in Milan on 18 and 19 September.
A wide-ranging event, dedicated both to the vertical aspects linked to the products of the pharmaceutical sector, and to the transversal service themes, such as certifications, distribution channels, logistics and the market.
On this occasion, the main operators in the sector met and some interesting points of reflection emerged.
The event was also attended by a delegation of Aervaro, always attentive to catching market trends, in particular with regard to value-added logistics services supporting the pharmaceutical sector.
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We met some of the more than 100 operators present and found that most of the players are strongly interested in supporting their core business with advanced logistics services, able to guarantee the preservation and transport according to the drugs.
Aervaro, thanks to its warehouse equipped with a temperature cell and to the network of carriers with temperature vehicles, can be the ideal logistics partner to meet these needs.
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Making Pharmaceuticals’ agenda was really full of interesting conferences and points for inspiration.
“The excellence of the Italian pharmaceutical supply chain: challenges and opportunities”
It is one of the conferences that opened the first day of work.
The excellence of the supply chain is certainly guaranteed by the observance of numerous parameters, such as certification of suppliers, certification of procedures, tracking of serials and sections.
“Supply chain control: import, transport, distribution and control of active substances. Presentation by Aifa, the Italian drug agency “
In this session the speakers strongly insisted on the need to make use of qualified and certified service providers. It is essential to include in the selection and collaboration processes with suppliers moments of in-depth control of compliance with all the quality parameters.
To manage pharmacologically active substances, it is necessary to use services provided by Aifa accredited production and logistics collaborators.
Very strict and restrictive accreditation criteria are also provided for imports of active pharmacological substances.
Importers can be pharmaceutical workshops, medicine manufacturers, and AIC holders.
If the active substance is intended for production workshops, medicines or other active substances, the importer must ensure a documentary check of the guarantee and safety of the active substance itself.
The observance of these procedures is also part of the GMP, good manufacturing practices.
The documentary quality check includes the following steps:
– Availability of a POS that defines the execution of the complete analysis, on all imported lots
– Specifications for the analysis of the imported substance
– Manufacturer release specifications
– Analytical validation report on at least 3 imported batches of substance
– For substances (API) that require controlled temperature guarantee of verification of the appropriate transport conditions.
Compliance with this procedure is monitored by the bodies in charge of control and GMP certification.
Often situations are detected in which the process is not implemented correctly, and one of the most frequent anomalies is the incorrect management of transport for substances that require controlled temperature maintenance.
GDP in the pharmaceutical business
Another very interesting conference was held by Assoram and concerned the importance of good distribution practices (GDP) for the pharmaceutical sector.
Today, logistics plays a strategic role in achieving excellent results for companies. The importance regards both the pure product handling service, especially if in the presence of special conditions (for example controlled temperature) and the correct management of information.
Today, pharmaceutical distribution logistics is provided by around 150 companies with around 250 warehouses in Italy.
The provision of a quality service is more than ever indispensable in a rapidly evolving sector, where in every phase of the distribution chain the possibility of tracking and analyzing transport conditions (track and trace) is required.
The role of logistics operators in accordance with the law becomes even more relevant with the expansion of online sales, where the product is transported to the consumer’s home.
Another conference of great interest was the one dedicated to ISO 9001 certification in the drug distribution chain.