By Alex Hall, Lead RSSL QP Tutor
The pharmaceutical industry in the UK is facing a shortage in the number of Qualified Persons (QPs). Evidence from the recruitment sector and the disparity in the number of QPs joining and leaving the registers maintained by the Joint Professional Bodies (JPB)1 support what has long been felt subjectively.
The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law. Indeed, every holder of a relevant Manufacturers Authorisation (MIA) (human and veterinary) must have at least one QP; without one, no batch of medicinal product can be certified for release for sale.
More products require QP certification
QP certification prior to release of medicinal products was first introduced in the EU in 1975 and the scope of certification activities has since been expanded, first to Investigational Medicinal Products and more recently to Herbal Products and Advanced Therapy Medicinal Products (ATMPs).
Changes in the UK manufacturing industry mean that there are fewer traditional pharmaceutical manufacturing sites, however, the proliferation of ‘virtual’ and other non-traditional holders of Manufacturers Authorisations, plus the increased expectations placed on the QP from regulators mean that demand for QPs remains high.
Number of Active QPs in UK industry
The number of QPs who are active, i.e. named on a Manufacturers Authorisation and certifying product, is difficult to calculate due to some MIAs having multiple QPs and some QPs being named on multiple MIAs. In addition, the registers held by the JPB may not indicate whether a QP is active as some may choose to remain on the register even if they have moved out the QP role or retired.
It is estimated that there are fewer than 1,000 active Qualified Persons in the UK at the current time.
Attaining QP status
The Joint Professional Bodies, who administer the assessment and examination process in the UK, have issued Guidance on the process for attaining QP status. It must be noted at this point that the process is EU Member State specific, and other states have different procedures.
In the UK, organisations with best practice in training QPs are those who understand the guidance and have fully integrated training, personnel development and career progression schemes in place to implement a succession planning strategy.
Training less expensive than recruiting in the long term
Employers may consider training QPs to be time consuming and prohibitively expensive, however, the expense of recruitment has increased significantly as the shortage has increased.
Whilst there are costs associated with training, especially academic training that involves many lectures and time away from the plant, it is possible to train otherwise talented/experienced individuals to achieve QP status.
To achieve this, training can be focused on knowledge gaps, with built in support and mentoring to utilise the existing knowledge and experience of quality professionals which encourages them to use their new skills in the business. Such support is more likely to better prepare the candidate for their viva.
The QP does not need to know 'everything about everything'; they do need to understand issues that are bought to them, know how to maintain oversight of complex systems and provide leadership to maintain compliance.
Need to train more QPs
Without manufacturers playing their part in meeting the need for training the next generation of QPs the industry will create a situation where QPs are attracted to the highest bidder, and the shortfalls can only be met by ever more expensive contract/agency staff.
With a better understanding of the process it is possible to increase the number of people being trained and available to act as Qualified Persons in the UK.
Holders of Manufacturers Authorisations can do more to support the trainees better and improve the pass rate, thereby providing business continuity and security for this essential element of the infrastructure for the UK pharmaceutical industry.
Reason for failing QP viva
From RSSL's experience of successfully* training QP candidates, it is apparent that those that succeed are the ones that are best prepared.
In interviews with a range of candidates who have failed the viva assessment, one consistent message is that they have experienced poor support by their employers and Sponsors, whilst often having attended lengthy or expensive academic courses in the mistaken belief that the course provides everything.
Better for the sponsor to pay for focused, shorter, interactive training from an external provider and offer more support to their candidate internally through hands-on experience and mentoring.
How to achieve success in QP Training
To succeed in training a Qualified Person the sponsor company should have a fully integrated training, personnel development and career progression scheme in place, in much the same way that usually exists for MBA students in management training.
This system needs to be documented and adhered to, and the QP candidate needs to be supported through the process. This is the route most likely to produce QPs who will remain with your company, who will be an asset in providing support when things go wrong, and will add value by supporting continuous improvement.
This will help your business keep ahead of the game with adherence to legislation and compliance, more than repaying the investment in QP training over time.
* First time pass rate > 90%1 Joint Professional Bodies (JPB) – Royal Society of Chemistry, Royal Society of Biology, Royal Pharmaceutical Society.