What is Good Distribution Practice (GDP)?

Good Distribution Practice (GDP) is a key component of drug safety. It describes the quality requirements for the distribution and logistics of human and veterinary medicinal products, as well as the active ingredients used in them, throughout the entire legal supply chain.

The aim of GDP is to ensure that the quality, safety, and efficacy of medicinal products are not compromised from the manufacturer to the point of delivery to pharmacies, hospitals, or other authorized entities.

While Good Manufacturing Practice (GMP) focuses on manufacturing activities, GDP directly follows on from GMP and governs all storage, transport, and distribution activities. Due to increasingly complex international supply chains and rising requirements related to the prevention of counterfeit medicines, GDP has gained significant importance in recent years.

Regulatory Basis

The key legal basis for GDP in the EU is:

• EU GDP Guidelines for medicinal products for human use: The "Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)" establish standards for the proper handling, storage, and transport of medicinal products. Compliance with these guidelines is a prerequisite for obtaining and maintaining a wholesale distribution authorisation.
• EU GDP Guidelines for active substances for human medicinal products: The “Guidelines of 19 March 2015 on the principles of Good Distribution Practice for active substances for human use (2015/C 95/01)” apply to the distribution of active substances intended for use in human medicinal products. Their purpose is to ensure that the quality and integrity of active substances are maintained throughout the entire supply chain.
• Good Distribution Practice for veterinary medicinal products: "Commission Implementing Regulation (EU) 2021/1248 of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council" entered into force in August 2021. This implementing regulation is closely aligned with the GDP guidelines for human medicinal products.
• Good Distribution Practice for active substances used as starting materials for veterinary medicinal products: Since August 2021, "Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council" has been applicable.

The following topics, among others, are covered:

• Quality system
• Personnel and responsibilities
• Premises and equipment
• Documentation
• Storage and transport
• Complaints, recalls, and returns
• Management of outsourced activities and supplier qualification
• Self-inspections

A central principle of GDP is the risk-based approach, which is aligned with the principles of Quality Risk Management.

In addition to EU requirements, several national laws and regulations govern the wholesale distribution of medicinal products.

In Germany, these include:

• Medicinal Products Act (Arzneimittelgesetz – AMG)
• Ordinance on the Manufacture of Medicinal Products and Active Substances (Arzneimittel- und Wirkstoffherstellungsverordnung – AMWHV)
• Ordinance on the Wholesale Trade in Medicinal Products (Arzneimittelhandelsverordnung – AM-HandelsV)

These regulations specify national requirements for the manufacture, storage, wholesale distribution, documentation, returns, and recalls of medicinal products and active substances.

In Austria, the wholesale distribution of medicinal products is governed in particular by:

• Medicinal Products Act (Arzneimittelgesetz – AMG)
• Medicinal Products Operating Regulation (Arzneimittelbetriebsordnung – AMBO)

Other European countries likewise have national laws.

In the United States, there is no standalone GDP guideline equivalent to that of the EU. However, comparable requirements are embedded within the regulatory framework, in particular through:

• Federal Food, Drug, and Cosmetic Act (FD&C Act)
• 21 CFR Parts 203, 205 and 211
• FDA guidances on Supply Chain Security and the Drug Supply Chain Security Act (DSCSA)

The FDA typically addresses distribution-related processes during GMP inspections or in the context of investigations related to counterfeit medicines, temperature excursions, or product recalls. 

Core GDP Requirements and Practical Implementation

GDP requires a documented and effectively implemented quality management system that covers all distribution activities. This system must ensure, among other things:

• clearly defined responsibilities
• established and controlled processes
• deviation management
• CAPA systems
• regular self-inspections

Senior management bears overall responsibility for compliance with GDP requirements.

A key element of GDP is the appointment of a Responsible Person, who ensures that all GDP-relevant processes are complied with. This person must have:

• adequate professional qualifications
• practical experience in medicinal product distribution
• knowledge of applicable regulatory requirements

and must be able to make independent, quality-related decisions.

Controlled storage and transport of medicinal products are also essential components of GDP. Key requirements include:

• appropriate storage conditions (e.g. temperature, humidity, light)
• qualified storage and transport processes
• monitoring and documentation of transport conditions
• handling of temperature-sensitive medicinal products (e.g. cold chain management)

Deviations, such as temperature excursions, must be assessed and documented and, where necessary, may result in quarantine or destruction of the affected products.

GDP requires complete and traceable documentation to ensure that:

• the origin of each medicinal product is known
• all distribution routes can be reconstructed
• affected batches can be rapidly identified in the event of a recall
• This is particularly critical in the context of counterfeit prevention and recall management.

Companies must establish clear procedures for handling:

• complaints
• recalls
• returns
• suspected or falsified medicinal products

Returned medicinal products may only be reintroduced into saleable stock under strictly defined conditions.

Practical Implementation of GDP

In practice, GDP requires not only the existence of standard operating procedures (SOPs) but also their consistent application in daily operations. Typical challenges include:

• interfaces between GMP and GDP
• external logistics service providers
• international supply chains
• digital temperature monitoring systems
• training of warehouse and transport personnel

The qualification and ongoing supervision of external service providers are particularly important, as outsourced activities remain the responsibility of the contracting company.

GDP Training

To ensure sustainable compliance with GDP requirements, regular training is essential. Recommended training measures include:

• basic GDP training for new employees
• training on deviation and recall management
• audit training for internal and external GDP audits
• regular refresher training

Such training not only supports compliance but also reduces the risk of deficiencies during inspections.

Working Groups and Further Information

Additional information, best practices, and opportunities for professional exchange are provided by, among others:

• The ECA European GDP Association
• specialist conferences such as the GMP & GDP Forum, which takes place every two years

These platforms help organizations identify regulatory developments at an early stage and translate them effectively into practice.