How to Assess Trainee Qualified Persons: A Case Study in GMP Excellence

Qualified Persons (QP) are required to have thorough understanding of pharmaceutical regulations and current Good Manufacturing Practice (cGMP), excellent technical knowledge and experience relevant to their dosage forms, strong leadership and interpersonal skills, the ability to handle pressure, and a commitment to risk-based decision-making.

Many companies look to develop talented individuals from within their organisation to acquire the necessary knowledge and experience to eventually act as a QP on their manufacturing licence. Given the required attributes of a QP, the personal time commitment, and the financial consideration of QP training, selecting the right candidate to put forward for training is of paramount importance.

As persons eligible to be nominated as QPs on UK manufacturing licences, and as ex-MHRA Inspectors, having been responsible for the assessment of the suitability of nominees, at EPiC we are uniquely placed to understand the importance of the QP role in protecting patient safety, in driving an organisation’s quality culture, and ensuring the timely availability of safe and effective medicines to patients in the UK and across the world.

EPiC were very happy to recently assist a UK sterile product manufacturing site with the selection of trainee QPs, by putting together and facilitating a multi-step assessment process, which looked to challenge candidates in a variety of ways, provide them an opportunity to share their knowledge and understanding of the role of a QP, and display some of the skills required.

Six-Stage Assessment Framework for Trainee Qualified Persons

It was important to us and our client that each candidate was given the same opportunity to showcase their abilities, both technical and interpersonal, in a variety of situations, to allow for an unbiased, evidence-based decision to be made. It was important to the client that each candidate could be assessed, and their strengths and weaknesses identified so constructive feedback could be given. It was also essential for all candidates to benefit from the experience and have development opportunities identified, especially those candidates who were not successful.

The QP assessment process we developed consisted of 6 stages:

Initial review and sift of applications and CVs – ensuring the minimum eligibility requirements for the QP role were met and that the candidates had some initial understanding of the role of the QP and the commitment required.
Panel interview – Existing QP, Quality Leader, and EPiC ex-MHRA Inspector, asked a mixture of technical and scenario-based questions to determine the candidates knowledge of the role of a QP and its legal basis, assess their understanding of the commitment required and the potential impact on personal time, and the candidate’s abilities regarding critical thinking, decision making with limited data, and application of quality risk management principles.
Group exercise – Candidates were observed by the existing QP, Quality Head, EPiC ex MHRA Inspector, and other members of the Senior Management Team, as a group working together to complete an initial root cause investigation into a real-life scenario. The intent was to assess each candidate’s approach to teamwork and observe them interacting with others. It was hoped that candidates would be engaged but not dominate and be capable of driving the process forward if it stalled. Candidates would also be willing to share knowledge, experience, and opinion but not to the exclusion of others.
Role Play – A meeting between the candidate and the Managing Director was role played, in which the candidate played the role of a QP informing the MD that they would not be certifying a batch due to a potential risk to product quality and patient safety. The intent was to see how the candidate reacted to pressure and if they could provide a reason why the MD arguments were not appropriate or complaint with GMP and articulate the impact of releasing the batch from a patient safety perspective, and the risks to the business from a regulatory and reputational perspective.
Candidate review and selection – Discussion between assessors / observers on the performance of each candidate at each of the stages. A scoring system was developed which allowed direct comparison between candidates as a starting point for informed evidence-based discussions which resulted in the identification of primary candidates and development opportunities for others.
Feedback to candidates – Verbal and written feedback was given to candidates on their performance during the assessment process in compliance with the client’s HR processes. The aim was to provide constructive feedback and identify development opportunities so even unsuccessful candidates obtained some benefit from the exercise.

Summary

With this assessment, 6 candidates were identified from stage 1 who were taken through the assessment process over the course of a day. Whilst the day was stressful for the candidates and hard work for the assessors, it resulted in some excellent discussions, the identification of some very talented staff members and relevant development opportunities, and two successful candidates to be put through QP training.

All in all a very successful exercise, and we at EPiC wish those trainee QP’s every success.

The EPiC team have a broad range of skills, knowledge and experience which many organisations and individuals have benefitted from through structured coaching, mentoring and projects such as this.

If you or you company would like to know more about the services we offer, please get in touch.

Transform Your QP Assessment Approach – Learn how EPiC’s six-stage evaluation process ensures GMP compliance and identifies top QP talent.