GDP Productsheet
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Certification according to Good distribution practice (GDP)
Quality Assurance in Pharmaceutical Distribution with GDP Certification
Manufacturers of pharmaceutical products are required to be able to demonstrate transparency and full traceability throughout the supply chain. The good distribution practice (GDP) guidelines support the pharmaceutical industry in reducing the counterfeiting of medicinal products and provide a uniform standard of assessment for quality at the same time. With the independent assessment of your compliance and GDP certification, you demonstrate that you are a reliable partner in the healthcare supply chain.
Benefits of GDP Certification
- Simplify your individual provision of proof
- Maintain the manufacturing quality of GDP medicinal products
- Benefit from worldwide access to markets through the internationally-recognized German Technical Organization for Safety, Quality and Environmental Protection (TÜO)
- Help the industry to uncover counterfeit medicinal products
GDP Certification at a glance
The GDP guidelines were published by the European Commission in 2013 to prevent counterfeit medicinal products and to ensure the quality of original medicinal products. The guide is aimed at wholesalers of medicinal products for human use who have wholesale licenses and all downstream transport companies, as well as couriers or pharmacies.
Our experts will support you throughout the entire process of your GDP audit. We carry out your certification with experience, efficiently and on a neutral basis, and also offer you the possibility of combined certification, with ISO 9001, for example.
- Project Meeting
Clarification of outstanding issues and determination of next steps - On-site GDP audit and documents review
Readiness analysis, description of your quality management system, verification of your quality capability towards your customers and implementation of the documented statements in your daily business - Audit report and assessment
Evaluation of the results, possibly with a presentation of potential for optimizations - Certificate and seal
After successfully completing the certification, you will receive your GDP certificate and the DEKRA seal (generally valid for one year) - Surveillance audit
A surveillance audit takes place every 12 months - Recertification
A recertification audit is carried out three years after the initial certification
The EU good distribution practice (GDP) guideline is based on the “Good Distribution Practice of Medicinal Products for Human Use” guidelines, which came into force in 2013 and stipulates requirements for guaranteed quality. These include:
- Quality management
- Personnel
- Premises and equipment
- Documentation
- Operations
At the same time, the GDP also contains guidelines to help prevent the counterfeiting of medicinal products, such as rules on:
- Returned medicinal product
- Suspected falsified medicinal products
- Outsourced activities
- Self-inspections
- Specific provisions for brokers
- Pharmaceutical transport
In this, it focuses primarily on the basic conditions in transport and logistics, such as temperature, humidity, IT networking and the checking of the serial numbers. All of the items are recorded in a quality management system. If this is implemented correctly, both the safety and quality of medicinal products is sustainably increased.
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Benefit from our longstanding experience in the area of pharmaceuticals logistics
- Save time and resources with our combined certifications and extensive portfolio of worldwide accreditations.
- You can trust in our expertise in management system certifications and pharmaceuticals.
- Secure the trust of your customers and business contacts with our recognized DEKRA seal and increase your competitiveness.
