GDP - Good Distribution practice
A Focus on Patient Safety - As a patient, you want to be certain that the quality of your medication remains unchanged throughout the chain of supply. How can you be sure that the pills that arrive at your hospital, your physician or pharmacist are identical to those shipped by the manufacturer?
As an organization that is part of this chain of supply, you can ensure this by complying with the EU Guidelines for Good Distribution Practice of medicinal products for human use. Its focus: distribution, security, temperature control, packaging quality and reliable, functional technology.
How it works
The EU Guidelines for Good Distribution Practice stipulate minimum requirements wholesalers and distributors need to fulfill when rendering services for the pharmaceutical industry. In addition, the Guidelines aim at minimizing the risks associated with transportation and storage of medicinal products. Compliance with these Guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products. GDP presupposes an effective quality management system, which allows organizations to implement the specific requirements of the GDP Guidelines with little effort.
Benefits of GDP Pharma:
- Significantly fewer individual customer audits
- Higher degree of transparency and reliability in the supply chain
- Noticeably fewer damages and loss
- Increased legal certainty and improved reputation
- Possibly lower insurance premiums due to recognition by insurers
The GDP Guidelines serve to ensure the suitability of distribution processes and the quality of packaging, as well as technological reliability and functionality. Accordingly, the assessment will focus on maintaining temperature control in all process steps. To this end, auditors will review technical facilities such as cooling units, sensors, mapping and monitoring as well as process safety, temperature documentation and emergency plans. An additional focus point is the security of the goods, in order to prevent theft or exchange. The certificate demonstrates successful implementation. Annual surveillance audits provide process stability and risk minimization. Recertification takes place every three years.Back to Specific Industries