What does the GDP drug storage legislation say?

The GDP drug storage regulation is one of the fundamental aspects to ensure the quality and safety of medicines during their transport and storage.

The GDP (Good Distribution Practice) legislation establishes the criteria for the correct treatment of medicines, with the aim of preserving their effectiveness and integrity until delivery to the final consumer.

In a highly regulated industry such as pharmaceuticals, strict enforcement of these guidelines is crucial to prevent product harm and ensure that medicines are always safe and effective.

Good Distribution Practices (GDP), regulated internationally by bodies such as the EMA, European Medicines Agency, strictly establish all the logistical phases of a medicine’s life cycle, with particular attention to storage.

These standards define specific requirements regarding the environment in which medicines are to be stored, such as temperature control, relative humidity level, ventilation, light protection, and how to secure and access warehouses.

From a GDP perspective, storage must take place in qualified facilities, equipped with continuous monitoring systems of environmental parameters, with alarms for deviations and emergency protocols.

The use of certified dataloggers, energy backup systems and plant validation procedures represent minimum standards for the correct application of the legislation.

The main objective of the GDP drug storage legislation is to ensure that medicines do not undergo alterations, contamination or chemical degradation that could compromise their efficacy, safety and quality until they are administered to the patient.

In detail, good GDP distribution practices prevent common problems related to improper storage, such as:

• Inventory errors due to untracked or disorganized inventory management.
• Cross-contamination caused by inadequate separation between different products (e.g. cytotoxic or refrigerated medicines).
• Temperature fluctuations that can damage thermolabile or biological drugs.
• Theft or tampering, thanks to the implementation of physical security and access control systems.

Failure to comply with GDP regulations can result in penalties, withdrawal of batches from the market and damage to company reputation.

For this reason, every player in the industry is required to train staff, implement standardized procedures, and adopt advanced traceability technologies (such as RFID or serialization) to ensure full regulatory compliance.

Relying on partners specialized in pharmaceutical logistics, such as Logistic Company, is a strategic step to ensure full compliance with the requirements of the GDP drug storage regulations, ensuring customers a reliable and certified supply chain.

In addition to GDP, another important regulatory reference for pharmaceutical companies is GMP (Good Manufacturing Practice).

These practices integrate with GDP so that every stage of a medicine’s life cycle is controlled, ensuring that products arrive at their destination in perfect condition.

GMP mainly applies to the production phase of medicines, defining the ideal storage environments before they are placed in the distribution chain.

Relying on a specialized partner is the ideal solution for pharmaceutical companies that want to be sure of complying with GMP drug storage regulations, subsequently applying the principles dictated by GDP.

Logistic Company is a GMP approved logistics operator and offers a highly qualified service for the storage of medicines, ensuring strict compliance with GMP and GDP regulations, thanks to temperature-controlled facilities and state-of-the-art monitoring systems.

In addition, the company ensures safe inventory management, preventing errors and damage, and ensuring that medicines are stored safely even during distribution.

On the occasion of Easter, our staff extends its most sincere wishes to all customers, partners and collaborators. Happy Easter from Logistic Company!