As a named RP on your licence, the responsible person will be held accountable for ensuring GDP is maintained throughout the business. The effectiveness of this will be assessed through the MHRA's inspection. The Inspector will review written procedures, use key performance indictors (KPIs) and assess the RPs competence through their training record as well as questions regarding the company’s Quality system throughout the inspection. Although RPs are permitted to delegate, the overall responsibility will rest on the RP. The role of an RP is in essence the head of GDP. To mimic the thorough insight into the company as the MHRA would have, Quality Reviews and Self-inspections are conducted by the RP with the assistance of relevant departments. Any findings are investigated and a risk reducing solution is implemented, with tracked and recorded documents.
The outcome of these reviews are an area of attention for the MHRA, as this shows if the company and its RP are self-aware, even if the outcome is less than favourable. The Inspectors look for proof that the RP is able to handle, communicate and implement positive changes that are in the name of GDP, even if the work load itself is co-ordinated throughout the company.