GDP – Buenas Prácticas de Distribución

The distribution of medicinal products, as well as the distribution of the active pharmaceutical ingredients (API) for medicinal products for human use, are key activities of the supply chain that should be under control in order to maintain the quality and the integrity of the medicinal products, as stated through Directive 2011/62/EU and related Guidelines 2013/C 343/01 and 2015/C 95/01 and current FDA initiatives and expectations

Due to the importance of distribution activities, regulation has become much more demanding and the pharmaceutical industry worldwide has increased efforts in order to ensure that active substances and medicinal products are properly managed.

The large experience of TDV, working for many years directly with the main actors involved in the supply chain, can provide an incomparable knowledge about the different needs and requirements of each step of the whole process, from the production of the active substances to the final distribution of the medicinal product.

The most relevant activities developed by TDV regarding Good Distribution Practice include:

  • Warehouse facilities and utilities qualification.
  • Quality system assessment and setup for logistic and distribution operations.
  • Optimisation of the supply chain and improvement of the supply chain control through a risk-based approach.
  • Preparation of regulatory inspections and inspections for authorisation of premises.
  • Assessment and GDP compliance.

For further information about GDP compliance, please contact:

Sandra Lacruz
slacruz@tdvct.com