Good Distribution Practice (GDP)

People responsible for ERP, logistics, or quality processes in a regulated pharmaceutical company with GDP-relevant logistics must comply with numerous requirements. This includes ensuring that manufacturing, storage, and transport of products – as well as the related documentation – are legally compliant and fully traceable.

GDP is mandatory and places high demands on processes, systems, and documentation. Software solutions such as ERP systems play a central role in implementing these requirements digitally, transparently, and efficiently.

Good Distribution Practice applies to all companies involved in the storage, transport, or distribution of medicinal products. This includes pharmaceutical manufacturers, wholesalers, logistics providers, and external partners such as software vendors that digitally support GDP-relevant processes.

Since the GDP guideline covers the entire supply chain of medicinal products – from dispatch to delivery to the recipient – all parties must meet the corresponding requirements. An official GDP certificate proves that a company complies with these regulations.

GDP is part of the so-called GxP requirements, which also include Good Manufacturing Practice (GMP), among others.

• Safety: Good Distribution Practice is designed to prevent counterfeit or stolen medicines from entering the legal supply chain. It strengthens patient protection and increases product traceability within the supply chain.
• Quality: GDP helps to maintain the quality and integrity of medicines throughout the entire distribution chain – from manufacturer to end customer. It ensures that medicines are packaged, stored, and transported under controlled conditions, thereby protecting their effectiveness.

• Compliance and suitability of packaging
• Temperature control during storage and transport
• Lot tracking across the entire supply chain
• Audit trail for all relevant actions and changes
• Complete documentation (e.g. transport data, inspection reports)
• Qualified suppliers and transport partners
• Regular quality audits and self-inspections
• Documented and tested emergency and recall procedures
• Training for all GDP-relevant employees

The European Union GDP guideline defines concrete requirements for all areas along the medicinal product distribution chain. It is divided into ten chapters, each containing specific provisions for quality, processes, and responsibilities. The objective is to ensure the safety and quality of medicines throughout the entire distribution process.

The ten chapters of the GDP guideline at a glance:

1. Quality management – Establishing an effective quality assurance system
2. Personnel – Qualifications, training, and responsibilities
3. Premises and equipment – Requirements for storage and transport environments
4. Documentation – Complete and traceable records
5. Operations – Organization and execution of distribution processes
6. Complaints and recalls – Handling returns, counterfeit medicines, and product recalls
7. Outsourced activities – Requirements for external service providers and contractors
8. Self-inspection – Internal audits to verify GDP compliance
9. Transport – Requirements for GDP-compliant transport of medicines
10. Specific provisions for brokers – Special requirements for medicinal product brokers

Further official sources & information:

• European Medicines Agency – Good Distribution Practice

Compliance with Good Distribution Practice is monitored by the responsible authorities of the EU member states. In Germany, this task lies with the competent inspectorates of the federal states.

During a GDP inspection, supervisory authorities check whether the requirements of the guideline are correctly and effectively implemented within the company. This includes examining facilities, logistics processes, as well as directive and evidence documentation. The aim is to ensure demonstrable GDP compliance.

Typical use case:
An ERP system – such as Yaveon 365 based on Microsoft technology – supports companies in systematically documenting all relevant GDP data, from supplier qualification to batch traceability. In this way, audit evidence can be provided digitally and in a compliant manner during inspections.

Good Distribution Practice is based on Directive 2001/83/EC of the European Parliament, in particular Articles 84 and 85b (3). These articles regulate the requirements for the storage, transport, and distribution of medicinal products for human use within the EU.

In Germany, the requirements have been transposed into national law through § 1a of the Ordinance on the Trade in Medicinal Products (AM-HandelsV). Among other things, this makes an effective quality assurance system mandatory for wholesalers.

GDP is therefore legally binding and provides the statutory foundation for the safe and traceable distribution of medicinal products in Europe.

In principle, any company involved in the healthcare supply chain can obtain a GDP certificate – provided they meet the requirements defined in the GDP guideline. This includes freight forwarders, warehouse operators, logistics providers, transport companies, and medicinal product brokers.

Certification is granted by the responsible supervisory authority and confirms that the company operates in compliance with GDP. It is often a prerequisite for approval as a service provider in pharmaceutical logistics and builds trust with clients in the pharmaceutical industry.

In addition, GDP certification can be a competitive advantage – it signals quality awareness, reliability, and regulatory expertise.

Certification under GDP takes place in several steps and is usually carried out by a competent authority or an accredited auditing body. The process includes:

1. Preparation & planning
   Clarification of open questions and definition of the audit scope as well as the next steps.
2. On-site audit
   Execution of a GDP audit at the company, including review of relevant processes, documents, and facilities.
3. Audit report & assessment
   Preparation of a report with an assessment of the results and, if necessary, recommendations for action.
4. Issuance of the GDP certificate
   If the audit is successfully passed, the GDP certificate is granted.
5. Regular monitoring
   A surveillance audit is usually conducted annually to ensure ongoing compliance with GDP requirements.
6. Recertification after three years
   After three years, a full recertification takes place, corresponding to a new main audit.

GDP transport ensures that pharmaceutical products are handled safely, efficiently, and in compliance with applicable regulations during transit. This practice is a central part of GDP pharmaceutical transport and includes measures to maintain the correct temperature, humidity, and hygiene in order to safeguard product integrity.

In addition, special packaging and continuous monitoring systems are required to minimize risks such as contamination and damage. By adhering to GDP guidelines in pharmaceutical transport, companies ensure that medicines reach the end consumer in perfect condition and without any loss of quality.

Yaveon’s industry ERP solution is a specialized system for companies in the process industry – with a strong focus on regulated sectors such as the pharmaceutical industry. The software helps ensure that the requirements of Good Distribution Practice (GDP) are implemented reliably and efficiently.

• Batch tracking and traceability: End-to-end tracking of every batch – from production to the end customer. This enables full transparency across the entire supply chain, as required by GDP.
• Quality assurance and control: Integrated inspection processes and system-supported documentation ensure that only quality-tested products enter distribution.
• Audit trail and compliance: Complete logging of all changes and actions (audit trails) enables audit-proof traceability – essential for GDP-compliant operations.
• Supplier and transport management: Supports the qualification and regular evaluation of suppliers and logistics providers, including audit planning and performance monitoring.