Qualified Person in the Pharmaceutical Industry

“Qualified person (QP) is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use). QPs are legally responsible for certifying batches of medicinal products before they’re used in clinical trials or available on the market.”

This legal definition is seemingly simple, but being a QP requires a lot of knowledge and experience in the field of pharmaceutical quality control. So how to become a QP in Poland? In the figure below, there are shown the key requirements according to European regulations.

Figure 1. Requirements to become a Qualified Person in Poland

Unfortunately, someone who wants to become a QP may encounter difficulties at the very beginning. Let’s look at sections #1 and #2 in the figure above. The broad knowledge and extensive experience are the crucial requirements. Due to the compulsory work experience, the majority of QPs come from pharmaceutical quality control laboratories. That’s why they have sufficient education and experience in laboratory work in different areas i.e. analytics, microbiology, or chemistry. However, they may have not enough knowledge in some subjects listed in section #1, where all of them are obligatory according to regulations. This is a huge obstacle to cope with before starting work as a QP. Although only pharmacists are knowledgeable enough in all of these fields, this gap can be easily overcome by participating in postgraduate studies designed for those with other education than the pharmacy.

If you are not a pharmacist, completing your education is just the beginning of your QP journey. QPs are obliged by law to constantly improve their qualification. It is quite logical if we take a closer look at the entire pharmaceutical industry which evolve so fast in past few years. New products, new quality control strategies, and globalization incessantly have an impact on the pharmaceutical supply chain. QPs need to deeply understand processes during the medicinal product life cycle, which can eventually affect the products’ quality. Of course, the final responsibility for quality, efficacy and safety of the pharmaceutical product lies on the product owner, but QPs are still personally responsible for certification and release of medicinal products’ batches to the market.

Continuing this thought, each manufacturing stage must be confirmed by QP, but there is a possibility that various stages can be confirmed by different QPs. This possibility enables pharmaceutical companies to outsource the manufacturing process or its part to the contract testing laboratories which can validate and conduct specialized quality control tests or even the whole panel of testing of a given medicinal product. Before outsourcing any laboratory work, the responsibilities of both sides’ QPs should be defined in detail in the quality agreement between the product owner and the contract laboratory.

Apart from confirming the manufacturing stages (i.e. laboratory tests), the contract laboratory’s QPs are involved in all processes important from the viewpoint of the Pharmaceutical Quality System (see figure 2).

Figure 2. Selected processes covered by the Pharmaceutical Quality System in which QP is involved

For more information regarding Qualified Person or medical products itself, the best idea is to read the official guidelines like EudraLex, which is a set of rules and regulations for medicinal products in the European Union. It contains ten volumes and each of them relates to a different topic. This article was prepared mostly according to volume 4 – Good Manufacturing Practice (in particular Annex 16), but there is also the whole volume about Clinical trials (volume 10), and one refers to pharmacovigilance (volume 9), which is the pharmaceutical science relating to adverse effects of the pharmaceutical product.

  • Author:

Ewa Matuszczyk
Quality Specialist/Qualified Person

References:

1. Journal of Laws, Act of 06 September 2001 Pharmaceutical Low
https://sip.lex.pl/akty-prawne/dzu-dziennik-ustaw/prawo-farmaceutyczne-16915922
2. EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines https://ec.europa.eu/health/documents/eudralex/vol-4_en
3. Directive 2001/83/EC for Medicinal products for human use https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf