Breakfast briefing takeaways: Quality Systems in Pharma – Who, What, When? 27 Feb 2023

PharmaMedic kicked off the first breakfast briefing of 2023 with a discussion about quality systems in the pharmaceutical industry and, specifically, the role of the Qualified Person (QP).

PharmaMedic’s Managing Director Malcolm Barratt-Johnson was joined for the presentation by respected, senior QP Indira Walker, Director of Iolite Pharma Consulting.

Malcolm opened proceedings with an overview of what quality means in the pharma industry, under the banner of Good Manufacturing Practice (GMP). He explained that quality was critical to sales, cost control, productivity, risk management and compliance. He said that GxP – where ‘x’ represented manufacturing, distribution, clinical, storage, or laboratory – was governed by guidelines originally established by the US Food and Drug Administration (FDA).

He described the five Ps of GxP as People, Procedures, Products, Premises & Equipment, and Processes, often with a quality management system underpinning them based on the principles of traceability, accountability and secure processes.

He impressed that every aspect of the manufacturing process had to be well documented through sound procedures, so that each step could be traced and proved to an auditor.

GMP set out the best practice methods that a company needed to achieve to satisfy the regulator (the Medicines and Healthcare products Regulatory Agency [MHRA] in the UK) that issued the manufacturer licence, he went on.

He concluded with a list of 10 principles of GMP, which, he believed, were hard to achieve in today’s complex medical and regulatory environment:

1. Design and construct the facilities and equipment properly
2. Follow written procedures and instructions
3. Document work
4. Validate work
5. Monitor facilities and equipment
6. Write step-by-step operating procedures and work on instructions
7. Design, develop and demonstrate employee competence
8. Protect against contamination
9. Control components and product-related processes
10. Conduct planned and periodic audits.

Next, Malcolm introduced Indira Walker, who went into detail about the varied role and responsibilities of a QP.

She explained that, essentially, the QP was responsible for certifying the release of every batch of a pharmaceutical product in the UK. The QP might certify both commercial and investigational medicinal products, or specialise in a specific area, such as veterinary or herbal products.

She outlined the qualifications needed to become a QP, as well as the training requirements, which encompassed law and administration, the role and duties of the QP, plus knowledge of pharmaceutical quality systems.

Then she explained the involvement of the QP in the development process, which began as early as possible – from early phase studies – as GMP applied at all stages. The QP needed to know as much as possible about the study design as well as the manufacturing and supply strategy. Later, the QP was also involved in post-marketing surveillance, complaint investigations and recall decisions, dealing with supply issues like shortages, post-approval changes to packaging or labelling, as well as the annual product quality reviews.

Indira listed some of the benefits of being a QP, including the fact that it was a position of responsibility and authority, with elevated professional credibility and reputation. A QP also had a broad range of career prospects.

In terms of challenges, she mentioned that there was a high failure rate for those applying to become QPs, which had led to a shortage of active QPs working in the industry. Training was also expensive, generally comprising a two-year course and two years of experience in an authorised facility. Employers also faced difficulties with retention, as many chose to become consultants.

She said that those who were able to absorb and analyse significant amounts of information and who could work under pressure and take – and justify – difficult decisions, which could have a negative commercial impact, would have the personal attributes needed to be a successful QP.

During the question and answer session at the end, one participant asked for further advice on how to become a QP, so there was interest from the audience in the role and an appreciation of the broad scope and responsibilities involved.

If you missed the event and would like to watch the replay, please click here.