In order to wholesale distribute medicinal products organizations must be in possession of a wholesale dealers authorization and fulfil certain obligations, one of which is to comply with the principles and guidelines of good distribution practice. When medicinal products are supplied or received a check to ensure the appropriate authorization is held needs to be performed. In addition where medicinal products are received from another wholesaler the receiving wholesaler must verify that the supplier complies with the principles and guidelines of good distribution practice. Part of this check is to ascertain if the supplier holds a GDP certificate
MHRA endeavor to perform re-inspections in advance of the validity date of the GDP certificate in order to ensure continuity of the documentation. However due to the risk based prioritization of resources this is not always possible and we are aware that some GDP certificates have now passed their validity date.
Where a sites GDP certificate has passed its validity date wholesalers should continue to perform their own checks to assure themselves that an appropriate authorization is held and the principles and GDP guidelines are being adhered to.
Checks to verify the supplier complies with GDP could include:
1. If they have more than one site, then reference to GDP certificates issued to other sites more recently
2. For established suppliers, a review of deviations / complaints / damages / returns records relating to the supplier
3. For new suppliers a declaration of GDP compliance provided by the RP
4. Evidence that a recent inspection has taken place which has yet to generate a new certificate.