Cold chain medicines: current situation and current regulations

Find out what the cold chain medicines are and the regulations in force to assure the safety and efficacy of heat-sensitive medicines. Read the news!

The cold chain in the pharmaceutical sector is a fundamental element to preserve the quality, efficacy and safety of medicines and pharmacologically active substances (APIs).

The cold chain, in fact, ensures that medicines are correctly maintained at ideal temperatures in every phase of the process, from production to storage to transport. Let’s find out all the details.

What is the pharmaceutical cold chain?

The pharmaceutical cold chain refers to all those procedures necessary to store and transport medicines at controlled temperatures, preserving their integrity and therapeutic efficacy, in compliance with the storage conditions authorised by the Authorities for each medicine.

The definition of the storage conditions of a drug is a fundamental part of the development studies of a drug: based on the results of standardized and controlled stability studies, the storage conditions that must be applied during the life of the drug are defined.

The cold chain process involves several phases, including production, storage and distribution, each of which requires rigorous monitoring of environmental conditions.

Importance of the cold chain in pharmaceuticals

Maintaining an adequate temperature is essential to avoid the deterioration of the active ingredients present in drugs: in fact, thermal fluctuations can compromise the effectiveness of medicines, making them ineffective or even dangerous for patients.

Therefore, accurate management of the cold chain is essential to guarantee the safety and quality of pharmaceutical products.

Current regulations on the pharmaceutical cold chain

Cold chain management is governed by strict regulations to ensure that drugs maintain their effectiveness until the moment of use. In Italy, the guidelines on Good Distribution Practices (GDP), defined by the Ministry of Health, establish the standards for the transport and storage of medicines, emphasizing the importance of temperature control.

In addition, the ATP Agreement, managed by the European Union, regulates the international transport of perishable goods, including pharmaceuticals, by establishing the conditions necessary for their safe and adequate transport.

This agreement defines the characteristics of the vehicles used, the temperature conditions and the operating procedures to ensure the optimal preservation of the goods during transport.

Cold Chain Management Challenges

Effective cold chain management presents several challenges, including:

  • Continuous monitoring: constant temperature control is required throughout all phases of the supply chain to prevent temperature excursions.
  • Adequate infrastructure: the use of warehouses and vehicles equipped with advanced refrigeration systems is essential to maintain optimal conditions.
  • Staff training: operators must be adequately trained to correctly handle temperature-sensitive drugs and address any critical issues.

Logistic Company: innovative solutions for the cold chain

To address these challenges, at Logistic Company we adopt cutting-edge solutions for cold chain management, with a strong commitment to innovation and safety.

Our warehouses are equipped with monitored cold rooms, powered by an autonomous photovoltaic system, which allows us to guarantee continuous temperature control, contributing to environmental sustainability by reducing our energy consumption.

Furthermore, we are among the first Italian warehouses authorized by AIFA and ATS for the management of pharmaceutical products and sensitive raw materials.

Discover our logistic services for pharmaceutical companies