GDP for APIs

Objectives

This course is intended to provide guidance on the provisions laid down in the EU GDP guidelines for APIs. You will get to know the key aspects of these guidelines and you will learn about

• What has to be considered regarding GDP-compliant storage and transportation of APIs
• How the exchange of information between agents, traders and pharmaceutical manufacturers should work
• Which risk assessment approaches are suitable and should be applied
• What authorities expect regarding GDP-compliant storage, transportation and distribution of APIs

Background

In March 2015, the “Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use” were published in the Official Journal of the European Union.

Since September 2015, the provisions of these Guidelines have been obligatory. The driving force behind these Guidelines is the combat against falsified drug substances and drug products. It is intended to control the entire supply chain and thus to mitigate the risk associated with complex distribution pathways. From now on, distributors are required e.g. to have a complete deviation management in place and to maintain a change management system as well as a CAPA system based on risk assessments. Moreover, a GMP-compliant complaint and recall management has to be established and a well trained staff has to ensure that all the requirements of the guidelines are met. In several sections of the Guidelines, it is pointed out that a thorough training of the employees is important.