Good Distribution Practice (GDP)

In principle, Good Distribution Practice applies to all companies that manufacture medicinal products and therefore mainly to companies in the pharmaceutical industry. As Good Distribution Practice covers the entire supply chain, from the sender to the recipient, it affects not only pharmaceutical manufacturers but also all those involved in logistics and the companies' software partners. A GDP certificate proves that these companies meet the necessary requirements. GDP is part of the GxP regulations, as is Good Manufacturing Practice.

The GDP guideline describes the requirements for all affected areas in a total of ten chapters. These are

1. Quality management
2. personnel
3. Premises and equipment
4. documentation
5. Operations
6. Complaints, returns, suspicion of counterfeit medicines, medicine recalls
7. Outsourced activities/contracted activities
8. Self-inspection
9. Transportation
10. Special regulations for intermediaries

GDP transportation ensures that pharmaceutical products are handled safely, efficiently and in accordance with applicable regulations during transportation. This practice includes measures to maintain the correct temperature, humidity and hygiene to ensure the integrity of the products.

In addition, special packaging and continuous monitoring systems are required to minimize risks such as contamination and damage. Compliance with GDP guidelines ensures that medicines reach the end user in perfect condition and without compromising quality.

The GDP inspectorates of the individual countries of the European Union are responsible for monitoring. They check whether the Guideline requirements are implemented in practice. To ensure this, premises, processes, specifications and verification documentation are inspected.

• Safety: Good Distribution Practice prevents counterfeit medicines from becoming part of legal pharmaceutical supply chains.
• Quality: GDP is a supporting factor in the control of distribution chains to ensure the quality and integrity of medicinal products.

Good Distribution Practice is based on Directive 2001/83/EC of the European Parliament and Articles 84 and 85b(3) thereof. In Germany, these guidelines are integrated into legislation via Section 1a of the Quality Assurance System of the Medicinal Products Ordinance.

Anyone involved in the healthcare supply chain can obtain GDP certification. The prerequisite is that the specified requirements are met. This includes freight forwarders, warehouse keepers, logistics service providers, transport companies and intermediaries. Certification enables entry into pharmaceutical logistics.

• First, open questions are clarified and the following steps are planned.
• An on-site quality audit is then carried out and the relevant or required documents are checked.
• An audit report is prepared and evaluated.
• Once certification has been completed, the GDP certificate is issued.
• From now on, a surveillance audit will take place regularly every 12 months.
• Recertification takes place after three years, and open questions are clarified and the next steps are planned.
• An on-site quality audit is then carried out and the relevant or required documents are checked.
• An audit report is prepared and evaluated.
• Once certification has been completed, the GDP certificate is issued.
• From now on, a surveillance audit will take place regularly every 12 months.
• Recertification takes place after three years.

Yaveon 365 is our industry-specific ERP designed specifically for companies in the process manufacturing industry. the solution helps ensure GDP compliance for pharmaceuticals.

Here are some of the possibilities:

• Lot tracking: Yaveon 365 enables detailed tracking of batches throughout the supply chain, which is a key aspect of GDP requirements. Each batch can be tracked from production to the end customer.
• Quality assurance and control: The software supports the implementation of quality control processes and ensures that quality checks are documented and monitored. This helps to ensure that only products that meet quality standards enter the supply chain.
• Audit trail and compliance: The software keeps detailed logs of all changes and activities (audit trails), which is important for traceability and compliance.
• Supplier and transportation management: The solution supports the qualification and monitoring of suppliers and transportation service providers to ensure that they meet GDP requirements. This includes regular quality audits and performance evaluations.