THE ROLE OF THE QUALIFIED PERSON (QP)
The elaborate nature of modern supply chains need a skilled person in charge of oversight. In the European pharmaceutical industry, this responsibility falls on a Qualified Person (QP). A QP will oversee the quality control systems at every stage of the manufacturing process of a drug – from how the active ingredients and excipients are made and shipped to the site, through to the packaging up of the final product.
It’s a big job, explains Alex Hall, a consultant senior Qualified Person (QP) and trainer for RSSL. "Medicines manufacture today is really complicated, because we’ve got a worldwide supply chain," she says.
"The active ingredient might be made in China, the tablets in India, and then they’re brought to the UK for packaging into different packages for different markets. The QP has to have oversight of all of that, to make sure that each and every batch meets the requirements set down in each product licence."
SO HOW DO YOU BECOME A QP, AND WHAT CAN IT DO FOR YOUR CAREER?
WHO AND HOW
European Union legislation dictates that a QP must have an undergraduate degree in pharmacy, chemistry or biology, and some practical experience in the testing, checking and quality assurance of medicines. "Lots of people come from an analytical chemistry or microbiological lab background," says Hall. ‘We also have people come in from a quality assurance or manufacturing site background."
In the UK, people who apply for QP status tend to already have at least five years of industry experience. Before training as a QP, Hall first worked in chemical and microbiological testing and then as a compliance officer for Roche Pharmaceuticals. Nina Dosanjh, a recently-qualified consultant QP, started her career as a development chemist for a couple of pharmaceutical companies before switching to a quality control role and most recently quality assurance secondments.
Both Hall and Dosanjh have undergraduate degrees in chemistry and are members of the Royal Society of Chemistry (RSC). To apply to become a QP, applicants must be members of the RSC, Royal Society of Biology or Royal Pharmaceutical Society. The three professional bodies work together to award QP status.
Prospective QPs are provided with an extensive list of the areas that they are expected to have knowledge and experience in. This ranges from legal requirements and best practice in managing quality control systems to a basic understanding of medicinal chemistry. Applicants are assessed against this syllabus, known as the study guide, through a written application form and an oral examination.
"Because the role is so broad, many applicants choose to attend courses, such as those run by RSSL, to fill in gaps in their knowledge. ‘Course providers have set up modules to map against the study guide," explains Hall. Prospective QPs can pick and choose which of modules they attend.
"There’s lots of self-study needed as well," Hall cautions. Dosanjh agrees: "The first weekend after I passed my exam, when I didn’t have to revise anymore, I wasn’t sure what I was going to do with my spare time!"
Originally published through Chemistry World.com, May 2019.
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RSSL also run a free seminar for people in the pharmaceutical industry to learn about the role of the QP and Sponsor. These seminars explore what is involved in becoming a QP, discussing the level of commitment expected of a QP, what you can expect from the RSSL training programme and the assessment process. Find out more and book a place.
For further information or to discuss your requirements, please contact the RSSL customer services team on +44 (0)118 918 4076 or email enquiries@rssl.com.