GDP: Good Distribution Practices: what they are and when they must be followed
Good distribution practices (GDP) are a set of standards and procedures approved at European level for storage and distribution centers that deal with drugs, food and natural products (such as supplements and nutraceuticals).
Maintaining the safety, integrity and quality of the pharmaceutical and natural product during distribution is already of the utmost importance in the pharmaceutical industry and the same attention is gradually also affecting the supplements and nutraceutical manufacturers.
The set of practices contained in the GDP is already formally accepted by important European countries such as Switzerland, Germany and France.
In Italy it is still good practice but of course the sector’s players who respect it are more advantaged at the competitive level.
In fact, thanks to the respect of these rules these subjects are able to demonstrate that their product is of quality and is effective not only at the time of production, but during all the phases of the distribution process, up to the moment of delivery in the hands of the consumer the final.
The application of GDP as a market success factor
Competition between companies happens as always on the market: it is the market that makes the laws.
Since maintaining the integrity of the products is essential for the success of the product and the company that produces it, it is important for these companies to align with the new European guidelines on good distribution practices (GDP), already published in the European official journal in November 2013, regardless of the formal transposition of the Italian Ministry.
In fact, Italy is still awaiting the formal transposition of GDP 2013 / C 343/01.
However, many operators in the sector, such as Aervaro, are already adopting these standards, thus proposing themselves as superior quality logistics partners for the Italian market, and already ready and compliant interlocutors for the European market.
Pharma & Natural Supply Chain phases
Today the distribution logistics enabled for the management of drugs and natural products is made up of about 300 authorized companies that have many warehouses with temperature-controlled cells.
The conveyor system is still often disorganized and does not always have the means to transport the products at a controlled temperature.
If we think of a drug or nutraceutical, we know that to be effective it must always be maintained at controlled temperature levels, in all stages of the supply chain, such as
- Storage
- Transport to and from producers for third parties
- Possible management of returns
- Lots and temperature tracking
- Stock and supply management
- Transportation to and from tens of thousands of points of sale (pharmacies, herbalists etc.).
About 80% of drugs and natural products are managed by wholesalers and distributors before reaching retailers and customers.
It is therefore a major responsibility entrusted to the actors of the supply chain.
To whom the GDP is released
To issue a GDP certificate an inspection is required and you have taken part in a specific preparation course.
After each inspection, the competent authority draws up a report on compliance by the interested party with the GDP principles and guidelines. Among the obligations of the holder of the authorization is to ascertain that the medicines received are not falsified or that they are always kept at a controlled temperature.
The responsibility of the Pharma & Natural Supply Chain Manager
The supply chain manager is an actor who has to make decisions daily at a strategic and operational level.
In the long term the supply chain manager collaborates with the other strategic company figures to ensure that the production and distribution of the products are always aligned with the law.
In daily life, it checks that processes such as storage and temperature-controlled transport are respected, and produces the documentation necessary to certify it.
The processes of the supply chain and the importance of having reliable partners
The main operational phases that a Supply Chain Manager must manage through are:
- evaluation and selection of suppliers of raw materials, products and services;
- supply flows and receipt of products;
- constant verification of environmental conditions (temperature, hygiene, brightness)
- acceptance and registration of products;
- storage and storage in accordance with the law
- inventory management and stock levels
- tracking (serial number, temperature conditions)
- documentation and certifications
- transport and monitoring
Not always all these phases are managed within the same company. In most cases, companies prefer to entrust one or more operations to qualified third parties.
In particular, the management of transport and temperature-controlled storage, complete with accompanying documentation, is often assigned to external partners but reliable, which become an integral part of the company’s supply chain process.
The strategic business choice between maintaining the logistics function internally or entrusting it to third parties specialized in the sector depends on numerous factors.
The outsourcing of logistic services is in constant development and wins that is already ready with the GDP
The logistics service partner receives the products directly from production, stores them, receives shipping instructions, prepares orders, sends them, transports them and delivers them, provides all documentation and fulfills accounting requirements.
It can perform a whole series of ancillary operations and processes such as re-packaging and re-labeling.
Furthermore, a specialized company can better guarantee service, quality, but also flexibility with respect to variations in volumes and customization of delivery conditions.