Responsible Person in Good Distribution Practice
The Gold Standard in Responsible Person training
When companies invest in upskilling, one of the key factors to consider is the ability to demonstrate that delegates receive consistent quality training and that learning outcomes are meaningful and measurable. This is particularly important in the highly regulated environments within the science industries.
One of the ways that companies can gain reassurance that their Responsible Person delegates are being trained to the right standard is to procure training that has been mapped to the Responsible Person Gold Standard.
Training providers may align their training with the Responsible Person Gold Standard and then apply to have their course recognised by Cogent Skills and the MHRA. The recognition is a result of a robust QA process of mapping the provider’s course to the RP Gold Standard, which then provides successful delegates on the courses with Cogent Skills / MHRA certificates.
Over recent years the Medicines and Healthcare products Regulatory Agency has tried to raise the profile of the important role of the Responsible Person (RP). Where deficiencies are cited against the RP this sometimes results in the licensing authority taking action by compulsorily varying the licence to remove an RP.
The licence holder is required to provide an RP with adequate knowledge and experience, learning ‘on the job’ is usual in this industry but experiential training can only provide for some elements of the full package. There is a place for good quality external training and this should be considered by all licence holders. Before arranging any external training, the Licence Holder and RP should be fully aware of the collaborative work on the Responsible Person Gold Standard between the GDP Inspectorate and Cogent Skills.
There is, effectively, a hierarchy of RP training provision in the UK.
Certification: Once you have demonstrated that you have met the learning objectives, you will receive a certificate showing that you have had training that meets the requirements of the Responsible Person Gold Standard.
Pharmacy Consulting Limited
NSF Health Services
Reading Scientific Services Ltd
We completely support the decision by industry to adopt the Gold Standard framework to standardise the requirements for the Responsible Person as it will generate a template for excellence in this role for the future.
Mark Birse, Group Manager GMDP Inspections at MHRA