The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK SI 2004/103). Every holder of a relevant Manufacturers Authorisation (human and veterinary) must have at least one QP; without one, no batch of medicinal product can be certified for release for sale.
At the end of 2014, with new, stronger guidelines1, more product types2 requiring QP certification than ever before, a shortage of suitable qualified and experienced QPs is the last thing the UK industry needs.
However, it is clear that the concern of many years past is now a reality. Specialist recruiter’s state filling permanent full time QP roles is now increasingly difficult with many QPs choosing lucrative contract positions and few new QPs qualifying each year (Figure 1) to replace those moving out of the role due to career progression or retirement.