WHO publishes revised draft on GTDP for pharmaceutical starting material

The WHO guide on Good trade and distribution practices for pharmaceutical starting materials was published in 2003. In 2006, the International Pharmaceutical Excipients Council (IPEC) – an industry association comprising excipient manufacturers, excipient distributors and their pharmaceutical customers – published its GDP Guide for pharmaceutical excipients, which was fully aligned with the WHO document.

Since the publication of these guidelines, a number of new developments and concepts, including, for example, risk management, have influenced good distribution practices (GDP) principles and processes. It was noted that a number of recent incidents have created awareness of the need for further improvement of the present guidelines.

The IPEC Federation proposed a revision and update of the WHO good trade and distribution practices (GTDP) guide and offered its support in providing a proposal. Following adoption, the IPEC Federation would then update its own guide in line with that of WHO. The Expert Committee discussed the need for revising and updating the WHO GTDP guide and endorsed the proposal.

You can find the revised text for comments in the ECA Members area.

Here you can find the current IPEC Guide on Good Distribution Practices for pharmaceutical excipients