GDP – Good Distribution Practice
GDP stands for Good Distribution Practice. It covers quality assurance requirements for the distribution of medicinal products. In the EU, the GDP guidelines address responsibilities, documentation, storage and transport, among other topics. Their purpose is to maintain the quality and integrity of medicines throughout the distribution chain.
What does this mean for temperature-controlled transport?
- The conditions specified by the manufacturer must be maintained. Transport operations and the protection required are planned on the basis of risk.
- Suitable equipment, trained personnel and traceable procedures support consistent execution.
- Temperature excursions are recorded, investigated and handled under the quality procedure. Monitoring provides the associated measurement data.
Can an insulated shipper alone be GDP-compliant?
Packaging can support compliance and be qualified for defined conditions. However, GDP applies to the entire process, including responsibilities and documentation. An insulated container or an individual test report therefore does not replace an appropriate quality system. A product name must not be taken to imply a specific certification or regulatory assessment.
Related terms: Qualification · Packing instructions
Technical references:
EU GDP guidelines: particularly Chapter 9