Protecting the quality of our medicines

What led you to becoming a Qualified Person?

I always enjoyed science at school and had some good science teachers. I finally decided on studying chemistry at university because I had enjoyed the subject and knew that it offered a good number of career paths.

Following graduation, I applied for various jobs that would make use of my chemistry background, and I was offered a job as Quality Control Analyst at a pharmaceutical company.

This was my entry into the field of pharmaceutical manufacturing. At the time I knew nothing about this industry or its regulations. Over the years I learnt a lot about quality control testing, quality management systems and tablet manufacturing and packaging.I always admired the knowledge of the Qualified Persons (QPs) I worked with, so when the opportunity arose to train as a QP, I saw it as a career move that I would enjoy and find beneficial.

I enjoy using my technical knowledge and industry experience in this role to assist in the release of batches of medicines and solving issues when
they arise.

What does being a QP involve?

The EU Directive 2001/83/EC requires each batch of pharmaceutical product to be certified by a Qualified Person before use. I am named on my company’s manufacturing licence as a Qualified Person, meaning that I work as part of the wider Quality Assurance team to assure the safety and quality of the items we produce.

As QP I have three main areas of responsibility:

• I perform the certification of batches of investigational medicinal products, ie new medicines that are still being tested, before they are used in clinical trials.
• I also prepare QP Declarations, which confirm that all non-EU sites involved in production are using standards equivalent to those used within the EU.
• And I work with production staff to ensure that packaging is compliant with regulations.

What training did you need for becoming a QP?

To become a QP you need to demonstrate a detailed knowledge of and experience in a wide range of areas of pharmaceutical manufacturing and legislation. This includes law and administration, quality management systems, medicinal chemistry, microbiology and pharmaceutical manufacturing, packaging and testing.

Most people undertake a course of additional study for two or three years to build up their knowledge to support the experience they gain working in the industry. In order to become eligible to act as QP, you apply via your professional body, in my case the Royal Society of Chemistry. Each applicant’s experience is assessed and – if deemed appropriate – you are invited to the final oral assessment.

You achieved CChem status through our new simplified procedure for QPs. Can you tell us about your experience?

Under the new procedure, becoming eligible to act as a QP counted for 75% of the CChem application. I only had to provide additional evidence in the three remaining areas. This made the process relatively quick to complete. And it was great to have all the hard work I had to put into becoming a QP acknowledged as professional development that directly links with the chartered status.

Training to be a QP was my professional development for about three years. Now I am a QP I have a duty to keep my knowledge of the regulations and new manufacturing processes up to date. I use the Royal Society of Chemistry continuing professional development tool to keep track of my development throughout the year.

Chartered status for QPs

A Qualified Person (QP) is responsible for certifying the suitability for release of every batch of a pharmaceutical product. We assess the eligibility of our members for QP status on behalf of the Department of Health and the Department for Environment, Food and Rural Affairs.

Recognising the substantial training that QPs have to undergo, we recently simplified the procedure for QPs to achieve chartered status. The CChem award recognises experienced practising chemists who demonstrated in-depth knowledge, significant personal achievements, professionalism and a commitment to continuing professional development. The simplified process recognises that QPs have fulfilled most of the necessary twelve professional attributes through their QP training.