Since the issue of the current EU Guidelines on Good Distribution Practice (GDP) of medicines for human use, we have been asked by several distributors to review their quality system against the Guidelines. The most common gap, that we see, relates to qualification of Suppliers and the additional information and checks that are required to ensure that medicines are only purchased from distributors that are authorised to supply them and are GDP compliant.
Obtaining a copy of your supplier’s Wholesale Distribution Authorisation (or national equivalent) is no longer sufficient on its own, proof of GDP Compliance is now required. One way of obtaining this information is via the EudraGMDP website:
Click on the Read-only access to GMDP tab which will take you to where you can see WDAs & GDP Certificates that have been uploaded by the competent authorities.
You must enter the country information and the supplier name (using an asterisk (wildcard) before and after the company’s name will help – i.e.: John Smiths Ltd, search *John* or *Smith*).
As the GDP Certificates are only uploaded after a Competent Authority Inspection, the one that you require may not be there therefore you will need to look at other methods of assessing GDP Compliance, i.e.: previous Competent Authority letters issued at the time of the last inspection or an audit of the supplier’s premises and procedures.
If you would like any advice or assistance with assessing your supplier’s GDP compliance, call PCL on 01252 302242
Dawn Chivers