Good Distribution Practices

The current globalization and offshoring of the pharmaceutical industry means that the supply chain for medicines and active ingredients is increasingly complex and involves a greater number of agents.

In this environment, the distribution and transport of medicines and active ingredients (APIs) for human use are key supply chain activities that must be controlled in order to maintain the quality and integrity of the medicines, as set forth in the European regulations, 2011/62/EU and related Guides 2013/C 343/01 and 2015/C 95/01, as well as current FDA initiatives and expectations.

 

The distribution and transport of medicines and active ingredients (APIs) are key activities in the supply chain.

 

The Pharmaceutical Industry, as well as regulatory agencies, are increasing efforts to ensure that active substances and medicines are properly managed throughout the supply chain.

The trend in the regulations governing the pharmaceutical environment is for compliance to be carried out from a risk management perspective. Risk management allows the identification of the agents or activities with a higher potential risk, thus investing resources in the most effective way and establishing the necessary tools to maintain the quality and integrity of medicines.

 

TDV’s wide experience working both with pharmaceutical laboratories and directly with the main actors involved in the supply chain, allows us to address different risk management strategies and to easily respond to issues such as

  • How to identify all the actors involved in the supply chain?
  • What controls should be established along the supply chain?
  • How responsibilities along the supply chain should be defined?
  • Who should have a GDP certificate for the distribution or transport of medicines?
  • What is a GDP certificate and who can issue it?

 

Services provided by TDV related to Good Distribution Practices include:

  • Advice and compliance with GDP for distributors and transporters.
  • Optimization of the supply chain and improvement of control in the supply chain through a risk management approach.
  • Preparation of regulatory inspections, for the authorization of facilities.
  • Qualification of facilities and warehouse utilities.
  • Advise and preparation of the Quality System for logistics and distribution operations.

 

Project Compliance Lifecycle:

For more information on GDP compliance contact:

Jorge Kucharski
jkucharski@tdvct.com

Read more about our Case Studies, news and related articles.

 

Case Studies