MHRA refers to the Gold Standard for Responsible Person

Recommendation

Monday, 28 September 2020 14.00 - 15.30 h

Webinar: The Risk-Based Approach and GDP

In our Newsletter we reported about a so called Gold Standard for the qualification of a Responsible Person for GDP. The recently published document by a group called Cogent SSC provides some information about what could be part of a job description for a RP on GDP. As a consequence these tasks, skills and responsibilities might be trained to make sure that the person in charge of that function will be qualified for the job.

A Press Release by Cogent cites Mark Birse, Group Manager GMDP Inspections at MHRA with the words: “Responsible Persons play a vital part in ensuring the quality and the integrity of medicinal products are maintained throughout the distribution chain. It’s essential that they have the right knowledge, demonstrate competence and deploy the right skills so that patients and healthcare professionals have the confidence and trust to use medicines. 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.”

Now the MHRA published a reference to the Cogent Gold Standard Document on their webpage.