Cogent
Cogent SSC is pleased to announce a new Gold Standard role profile for the responsible person (RP) in medicinal products. The release of the RP Medicinal Products Gold Standard follows extensive discussions with pharmaceutical companies, the regulator — the Medicines and Healthcare products Regulatory Agency (MHRA) — and Cogent (the national skills body for the science industries).
The Gold Standard is a competency framework for individuals in the science-based industries. It sets out an industry standard for expected levels of on-the-job performance. It supports continuing professional development (CPD), setting out the skills required for world-class performance in key job roles. The Gold Standard job roles are developed by sector employers using the four skills areas: technical competence, compliance, business improvement and functional and behavioural. The defined job role skills are much broader than technical and seek to equip an individual with a world-class skill set.
Mark Birse, group manager GMDP inspections at MHRA, commented: “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.”
The RP Medicinal Products Gold Standard sets out an industry agreed framework that identifies the skills required by a responsible person in four skills areas. This spread of skills ensures that the role includes not only the traditional qualifications and technical requirements but also the behavioural skills required to do the job to a high standard. These include business improvement, leadership and communication.
John Holton, operations director at Cogent, said: “It is a fantastic step for the pharmaceutical industry in developing a clear standard for the responsible person role to meet their requirements. The Gold Standard framework provides a solid foundation on which the industry can build a workforce, which is not only technically skilled but also competent in the wider demands of the role that are not taught as part of a qualification or course.”
The final version of this Gold Standard was approved in March 2014 by industry through the Cogent Pharmaceuticals Manufacturers Advisory Council (PMAC) and is now freely available for use via the Cogent and MHRA websites.
View the RP Medicinal Products Gold Standard at www.thegold-standard.co.uk/job-details/?jobid=297.