How can a GDP certificate or GDP certification be obtained?

Good Distribution Practice (GDP) is a core element of quality assurance within the pharmaceutical supply chain. It ensures that medicinal products maintain their quality, safety, and efficacy during storage, transport, and distribution.

Companies that distribute medicinal products or provide logistics services within the pharmaceutical sector are often faced with the question of how compliance with GDP requirements can be demonstrated. In this context, the terms “GDP certificate” or “GDP certification” are frequently used. However, these terms refer to different concepts and must be clearly distinguished from one another.

In principle, a distinction must be made between authorisations granted by competent authorities and voluntary, commercial GDP certifications. These instruments pursue different objectives, have different legal effects, and are relevant to different stakeholders.

Regulatory Framework

The primary regulatory basis for GDP in the European Union is the “Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)”. These guidelines are binding for all holders of a wholesale distribution authorisation and set out detailed requirements relating to:

• quality management systems
• personnel and responsibilities
• premises and equipment
• documentation
• storage and transport
• management of deviations, complaints, and recalls

The EU GDP Guidelines generally apply to all companies that distribute medicinal products within the EU or supply medicinal products to the EU market.

While the EU GDP Guidelines provide a harmonised regulatory framework at Union level, their implementation and enforcement are carried out at national level by the competent authorities of the individual EU Member States. Each Member State transposes the GDP requirements into its national legal system through specific laws, ordinances, and administrative procedures governing wholesale distribution activities.

As a result, the formal structure, terminology, and administrative processes for demonstrating GDP compliance may differ between Member States, even though the underlying GDP principles and technical requirements are aligned across the EU. These national frameworks typically regulate, among other aspects, the granting of wholesale distribution authorisations, the designation and qualification of Responsible Persons, inspection frequencies, and notification obligations in the event of significant operational changes.

Germany may serve as an illustrative example of this national implementation approach. In Germany, GDP requirements are embedded in national legislation such as the Medicinal Products Act (Arzneimittelgesetz - AMG) and supplemented by specific ordinances governing wholesale distribution and regulatory oversight. Comparable national legal frameworks exist in all other EU Member States, administered by their respective competent authorities.

Outside the EU, there is often no direct equivalent to the European GDP authorisation. In the United States, requirements relating to storage and distribution arise, among others, from:

• current Good Manufacturing Practice (cGMP) regulations (21 CFR Parts 210 and 211)
• supply chain security requirements, such as those under the Drug Supply Chain Security Act (DSCSA)

What Does a “GDP Certificate” Actually Mean?

In practice, the term “GDP certificate” is used inconsistently and may refer to different situations, including:

• a wholesale distribution authorisation (WDA) issued by a competent authority
• a positive outcome of an official GDP inspection
• a commercial GDP certification issued by a private certification body

Obtaining an Official GDP Authorisation (Wholesalers)

Companies that purchase, store, possess, or sell medicinal products at wholesale level must obtain a wholesale distribution authorisation from the competent authority of the relevant EU Member State prior to commencing operations.

The application typically includes, among other elements:

• corporate documentation
• a description of the scope of activities
• nomination and qualification of the Responsible Person
• description of premises and technical equipment
• documentation of the GDP quality management system

The application must be submitted before the start of operations. Commencing wholesale distribution activities without a valid authorisation is not permitted.

Following the assessment of the submitted documentation, an on-site inspection is generally conducted by the competent authority to verify compliance with GDP requirements.

If all requirements are fulfilled, the competent authority grants the wholesale distribution authorisation. Such authorisations are typically:

• site-specific
• activity-specific
• valid for an unlimited period, provided that compliance is maintained

The granting of an authorisation does not end regulatory oversight. Wholesalers remain subject to ongoing supervision through periodic GDP inspections. These inspections assess continued compliance with GDP requirements and the appropriate management of operational changes.

Significant changes, such as relocation, replacement of the Responsible Person, or expansion of the scope of activities, are subject to notification obligations towards the competent authority in accordance with national requirements.

Logistics Service Providers

Companies that exclusively provide transport or logistics services generally do not require a wholesale distribution authorisation. However, this may depend on the specific national regulatory framework of the EU Member State concerned. Nevertheless, such companies must operate in compliance with GDP requirements, as they form an integral part of the pharmaceutical supply chain.

In this context, commercial GDP certificates may play a supportive role by providing an initial indication of a service provider’s quality level. However, they must not be regarded as a substitute for the contracting party’s own qualification activities. Competent authorities explicitly expect pharmaceutical companies to perform their own assessment of service providers.

Responsibility for the qualification of logistics service providers lies with the pharmaceutical contracting parties, for example through:

• audits
• quality agreements
• performance monitoring using KPIs/QPIs (Key Performance Indicators / Quality Performance Indicators)

Certificates may serve as an additional source of information but do not relieve companies of their obligation to perform a risk-based evaluation.

Commercial GDP certificates may therefore:

• serve as marketing and confidence-building instruments
• support customers in supplier selection
• help structure internal GDP systems

However, their evidentiary value is limited:

• certification bodies do not act as competent authorities
• formal accreditation is often lacking
• audit scope and depth vary significantly
• potential economic dependencies may exist

It is therefore essential to note that:

• GDP certificates do not replace customer audits
• they do not replace official authorisations
• they constitute only a supplementary tool

For more information on this topic, please see the webinar “Commercial GDP Certificates".

Typical Steps in Commercial GDP Certification

Regardless of the certification provider, commercial GDP certification typically follows these steps:

• gap analysis against the EU GDP Guidelines
• establishment or adaptation of the quality management system
• training of personnel
• performance of an external audit

Training as a Key Element of GDP Compliance

Comprehensive training is a fundamental prerequisite for any form of GDP certification. Typical training topics include:

• regulatory foundations of GDP (EU level)
• requirements for storage and transport
• temperature management and cold chain control
• audit and inspection preparedness
• GMP–GDP interfaces

Beyond formal training programmes, companies benefit from professional exchange, for example through working groups, expert forums, or conferences.