As a consequence from the extensive globalization, the relevancy of good distribution practice (GDP) of medicinal products is growing rapidly. With the recent GDP guidance published in November 2013, the European Commission has specified the GDP and GTP requirements in much greater detail. This is not only a regulatory reaction to an increasing incidence of falsified drug products along the legal supply channels. The guidance provisions now also take into consideration today´s much higher potential for impact on drug product quality and safety due to transport and distribution conditions.
We welcome You to benefit from our experience, acquired during several years of specialized company consulting and employee training in the area of GDP, GTP and supply chain management.
- Set-up and establishment of GDP, GTP and supply chain management
- Risk-based time-cost assessment
- Qualification of storage facilities, including validation and set-up of monitoring according EU GMP / CFR (where requested, service includes provision of temperature loggers)
- Transport validation
- Cold chain validation including holding times
- Validation of operative processes (e.g. picking and packing)
- Drafting of cost-efficient plans for monitoring of storage facilities and transport
- Audit support in controlling the distribution chain