The roles and responsibilities of the RP is becoming tougher, the roles can be delegated but not the responsibility thus the activities need to be delegated in a very clear and concise way to the team member who is tasked with carrying out the role. The RP must ensure that they are trained and that they are competent before they start and their competence is checked by way of audit.
Ok, so what does this mean?
Let’s look at supplier bona fides checks for example ….. If this is delegated to a team member how can we be sure that it has been done correctly? It is one of the most important GDP compliance checks you can to do and it must be carried out correctly.
If the supplier is in the UK and if they have no GDP certificate on the Eudra GMDP database what do you ask to be done? Do we ask them to print a copy of their check on the MHRA website and the lack of evidence of a GDP certificate on the Eurdra GMDP database and ask for it to be signed and dated for us to approve them? Do we send a pre-approval questionnaire and let them assess it? When do we insist on auditing the supplier to verify the approval process?
There is no set answer because there is not always enough time or resources to audit each supplier. But you must ensure that in addition to the quality bona fides checks that there is a need to carry out some due diligence checks such visiting their website, checking their VAT registration number and also the certificate of incorporation. You may also wish to set commercial boundaries and review the performance of a new supplier. If you have not reviewed or audited your supplier approval process for a while, take a look ASAP and ensure it is robust enough.
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