Expertise.
Good Distribution Practice (GDP) consulting.
Compliant?
Efficient?
Secure?
Ensure the GDP compliance of your supply chain.
Ensure GDP compliance along the supply chain.
Our GDP consulting supports you in successfully implementing the requirements along the pharmaceutical supply chain. GDP is crucial for ensuring quality and safety in the distribution of medicinal products. Our experts will support you from risk analysis and the introduction of a GDP-compliant quality management system through to continuous process improvement.
GDP is essential when it comes to ensuring drug safety and meeting legal requirements. Our tailor-made solutions support you in implementing robust processes, creating documentation and implementing sustainable supply chain management. We offer practical support for internal audits, the creation of SOPs and preparation for external audits. With our extensive experience in the pharmaceutical sector, we ensure that your supply chain complies with GDP standards and that you remain audit-ready.
Take advantage of our GDP expertise and ensure secure and efficient supply chain processes.
Discover our expertise in GDP Consulting.
GDP audits.
- Conducting internal and external GDP audits to ensure compliance along the supply chain
- Identification of weak points and development of action plans
- Support with audit preparation and follow-up
Quality management
systems in accordance with GDP.
- Development and implementation of GDP-compliant QM systems
- Creation of Standard Operating Procedures (SOPs)
- Support with official approvals, e.g. §52a AMG wholesale authorization
Transport and storage qualification.
- Optimization of storage and transport conditions through temperature mapping
- Validation of logistics processes for seamless GDP compliance
- Use of modern monitoring solutions to monitor the supply chain
Successful GDP projects.
Challenge.
Improvement of quality management to meet GDP requirements.
Measures.
- Introduction of a structured QM system in accordance with GDP
- Creation of SOPs for process safety
- Training employees to comply with the new guidelines
Results.
- Significant increase in process quality
- Successful official inspection without deviations
- Ensuring GDP compliance in the long term
Success.
The company was able to ensure robust GDP compliance and minimize risks in the supply chain.
Secure long-term competitive advantages through robust and compliant supply chain processes.
Our GDP service portfolio at a glance.
A central component of our portfolio is the implementation of internal and external GDP audits. Our experts identify weaknesses in your processes and develop specific action plans for improvement. In doing so, we take into account the current requirements of the European Commission's GDP guidelines and the German Medicines Act (AMG).
We support you in setting up GDP-compliant quality management systems and use modern technologies to seamlessly monitor storage and transportation conditions. Digital monitoring tools and real-time data analysis ensure transparency and traceability along the entire supply chain.
A structured risk management system is crucial for identifying, assessing and controlling potential risks along the supply chain. Equally important is effective deviation management for the systematic recording and processing of quality deviations. These measures help to increase process reliability and meet regulatory requirements.
Regular due diligence audits of suppliers and customers ensure that all partners in the supply chain work in compliance with GDP. By establishing qualification programs and audit strategies, the continuous evaluation and improvement of cooperation can be ensured.
The implementation of modern monitoring systems enables continuous temperature monitoring during transportation and storage. The use of IoT technologies enables real-time monitoring and documentation, which increases transparency and security in the supply chain.
The implementation of serialization systems makes it possible to uniquely identify each individual product and trace its path along the entire supply chain. This helps to ensure the authenticity of medicinal products and prevent counterfeit products from entering the legal supply chain. According to Directive 2011/62/EU of the European Parliament and of the Council, serialization is an important part of drug safety.
Developing and implementing contingency plans ensures that your company is prepared for unforeseen events such as natural disasters or supply disruptions. Effective business continuity management (BCM) ensures the maintenance of critical business processes and minimizes potential downtime.
In addition to the European GDP guidelines, it is also essential for globally active companies to take international standards into account. The WHO Guidelines for Good Distribution Practice provide valuable guidance on how to comply with global requirements.
Our training courses are aimed at operational teams, managers and GDP officers. In practical workshops and e-learning modules, we impart the necessary knowledge to successfully implement the GDP requirements in daily practice.
We support you in creating audit-ready documentation in accordance with regulatory requirements and accompany you during official inspections. With our help, you can ensure that all regulatory requirements are met and that your documentation is complete. We also use the WHO GDP inspection guidelines as a guide.
