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Pharmakon Life Science

What is GDP? Safe Distribution of Medicines

Understand the requirements for the storage, transport, and traceability of medicines.

What is GDP?

GDP stands for Good Distribution Practice.

GDP is the part of quality assurance that ensures that the properties of medicinal products are not compromised during storage and transport, and that defective medicinal products can be traced and recalled.

The EU defines the overall framework on which the Danish GDP rules are based.

 

It sounds simple – but in practice, it places demands on systems, equipment, and employees.

On this page, you'll find answers to:

  • What is GDP?
  • Why is GDP important?
  • Who is required to comply with GDP?
  • What does GDP entail in practice?
  • What is a Responsible Person (RP)?
  • What mistakes are commonly seen in GDP practices?
  • How do you comply with GDP in your everyday life?

Why is GDP important?

GDP ensures that medicinal products:

  • transported and stored under the right conditions
  • do not become too old, too hot, or too cold
  • not be exchanged or counterfeited
  • can always be traced—both forward and backward in the supply chain
Source: GDP guideline (2013/C 343/01), section 1.1

Who is required to comply with GDP?

The GDP applies to all companies that distribute human medicines in the EU—including wholesalers, distributors, carriers, and warehouses that handle temperature-sensitive products.

GDP applies to the entire distribution chain – from manufacturer to pharmacy, hospital, or distributor.

The company's management is responsible for establishing a quality system that meets GDP requirements and must take an active role in this work.

EXAMPLE: 

A medication that must be stored at 2–8 °C is delivered to a warehouse without temperature monitoring.

The package will be left in the sun at 28 °C for three hours.

No one notices it—but the product's effectiveness is now in question.

GDP is designed to prevent precisely this. If quality is not assured throughout the entire process, it can be dangerous for the patient.

What does GDP entail in practice?

GDP sets requirements for temperature control, traceability, approved suppliers, the separation of saleable and non-saleable goods, and documentation of all actions in the distribution chain. 

Wholesalers must also describe internal requirements for employee training in their quality management system and stay up to date on regulatory requirements.

What is an RP?

A Responsible Person (RP) is the designated individual within the company who is responsible for ensuring compliance with GDP regulations. The RP is appointed by management and must have the necessary competencies and authority to carry out this task.

The GDP guidelines describe the RP’s specific areas of responsibility, including responsibility for the quality system, employee training, and liaison with regulatory authorities.

Stay up to date

Wholesalers must describe internal requirements for employee training in their quality system.

When working in accordance with GDP, it is important to stay up to date with regulatory requirements.

Pharmakon's GDP courses provide you with knowledge of the regulatory requirements in effect at any given time—for professional development, training, and onboarding of new colleagues

Typical errors in GDP practice

The most common GDP violations involve a lack of temperature monitoring, improper handling of returned goods, and the use of unapproved suppliers.

  • Medicines are stored without temperature measurement or monitoring.
  • Transport is carried out without validated packaging or temperature control.
  • You mix saleable and unsaleable goods.
  • Returned items are put back into stock without being assessed.
  • Missing or incorrect registration of suppliers and customers.
  • Counterfeit goods are detected too late – or not at all.

How do you comply with GDP in your everyday life?

GDP is implemented in day-to-day operations by following procedures, documenting actions on an ongoing basis, using approved suppliers, and ensuring proper segregation and inspection of goods upon receipt.

  • Follow procedures and document your actions in a timely manner.
  • Only use approved suppliers and carriers.
  • Be sure to separate item types and items with different stock statuses.
  • Check for damage, labeling, and temperature upon receipt of goods.
  • Ensure that all relevant information is recorded and traceable.

Checklist: Are you complying with good GDP practices?

Questions Yes No
Is there temperature control throughout the entire storage and transport chain? ⬜ ⬜
Are all customers and suppliers approved and registered? ⬜ ⬜
Are returned goods handled correctly and documented? ⬜ ⬜
Is there a clear distinction between saleable and unsaleable stock? ⬜ ⬜

Do you need to refresh your GDP knowledge—or help new colleagues get started?

Here you will find knowledge that you can use for upskilling, training, and your work with GDP.

Use it in practice

  • Warehouse task: Walk around and check: Are saleable and non-saleable goods clearly separated? How is the temperature documented?