Reflecting on 50 years of the Qualified Person (QP) in Pharmaceutical Regulation
In 1975, European pharmaceutical regulation changed forever. With the introduction of the Qualified Person (QP) into law, responsibility for releasing medicines was placed squarely on the shoulders of a named, accountable professional.
Fifty years on, the QP remains the last legal and ethical checkpoint between a medicine and a patient.
In this episode of NSF’s Compliance Unlocked Podcast, Dr. Peter Gough returns to explore how the QP role has evolved over the past five decades and what lies ahead as decentralised manufacturing, artificial intelligence and new European legislation reshape pharmaceutical quality systems.
You can watch the full podcast episode below:
A journey through five decades of QP regulation
The QP role was created under EU Directive 75/319, introduced in 1975 for human medicines. It was modelled on the French system of the pharmacien responsable, where a senior pharmacist held corporate responsibility for the safety and legality of medicines. However, while the directive defined minimum education and experience, it left each Member State to implement its own rules.
In the UK, regulators concluded that no undergraduate degree fully covered the legal and scientific requirements of the role. Instead, responsibility was delegated to three professional bodies: pharmacy, chemistry and biology. This decision permanently shaped the UK QP landscape, creating a multidisciplinary profession rather than one dominated by pharmacists alone.
From fragmented systems to a unified professional standard
In the early years, each professional body assessed QPs separately. That changed in 1992, when the three societies created the Joint Professional Bodies (JPB), establishing a single, harmonised framework for QP eligibility in the UK.
Two documents became foundational:
- The QP Curriculum, defining what every QP must know.
- The QP Code of Practice, defining how QPs must act.
These were paired with formal viva examinations, where candidates are tested on real-world decision-making by panels representing all three professions.
This structure ensured that QPs were not only academically qualified but capable of exercising independent judgment under pressure.
Regulatory milestones that reshaped the QP role
Over five decades, the legal responsibilities of QPs have expanded dramatically. Major milestones include:
- 1981 – Extension of the QP role to veterinary medicines.
- 2001–2004 – Introduction of QPs for investigational medicinal products (IMPs).
- 2002 – First publication of EU GMP Annex 16, defining the QP’s operational
- responsibilities.
- 2011 – Falsified Medicines Directive, requiring QPs to certify API GMP compliance.
- 2016 – Major revision of Annex 16.
- 2026 (expected) – New EU Human Medicines Regulation introducing decentralised manufacture.
Each step has added legal, ethical and technical accountability, reinforcing the QP’s position as the ultimate gatekeeper between manufacturing and the patient.
Protecting patients in the real world
At the heart of the QP role lies one overriding principle: patient protection.
Pete explains that harm can occur in two ways:
- Through poor quality.
- Through lack of availability.
While most batches are clearly acceptable or clearly defective, the most difficult decisions lie in between.
The grey zone: where QPs really earn their money
Pete calls this the “grey zone.” These are cases where a batch does not perfectly meet expectations, but rejecting it may create a shortage that harms patients more.
He recalls a case involving an injectable antibiotic that turned pink due to oxidation. Although technically out of specification, regulators allowed continued supply until replacement stock was available because the colour change did not meaningfully affect safety or efficacy.
Why compliance is ultimately a human discipline
Modern pharmaceutical quality relies on systems, data and increasingly on digital tools. But Pete is clear that compliance does not come from paperwork; it comes from people.
A QP must build relationships across the organisation, from shop-floor operators to senior leadership. That trust allows honest reporting, effective investigations and the confidence to make difficult decisions when necessary.
The impact of Brexit on QP demand
Brexit fundamentally altered the status of UK-based QPs. Once the UK left the EU, QP certification issued in the UK was no longer recognised for products entering the European market.
This meant that medicines manufactured in the UK must now be re-certified by an EU-based QP, instantly increasing demand for QPs across Europe and adding complexity to supply chains.
The future: decentralised manufacturing, AI and the new EU law
Decentralised manufacturing
The forthcoming EU Human Medicines Regulation, expected in 2026, formally introduces decentralised and distributed manufacturing models into European law. This reflects a shift away from single-site production toward networks of manufacturing locations, including hospital-based and digitally connected facilities.
For QPs, this fundamentally changes accountability. A QP at the central control site will be legally responsible not just for one factory, but for ensuring GMP compliance, data integrity and batch oversight across an entire distributed network. This increases the complexity of the role and places even greater emphasis on quality systems, digital traceability and cross-site governance.
Artificial intelligence
AI is beginning to play a real role in pharmaceutical quality, from analysing trends and deviations to generating reports and reviewing data. These tools can help QPs process large volumes of information more efficiently and detect emerging risks earlier.
However, Pete stresses that legal and ethical responsibility does not move with the technology. A QP remains personally accountable for every decision and must ensure AI outputs are reviewed, challenged and understood before being relied upon.
New EU medicines legislation
The next major regulatory shift is the new EU Human Medicines Regulation, currently moving through the EU’s trialogue process between the European Commission, Parliament and Council. Drafts have been published between 2023 and 2025, and negotiations are now underway to finalise the law.
Once adopted, it will replace key elements of the existing framework and introduce new legal concepts such as decentralised manufacturing and updated batch certification responsibilities. QPs will be at the centre of turning this legislation into compliant, practical operations across the industry.
Why QP training matters more than ever
With over 35 years of QP training heritage, NSF has supported thousands of professionals preparing for this demanding role.
QP training develops not only regulatory knowledge, but the judgement, critical thinking and confidence required to make high-impact decisions that protect patients and companies alike.
Learn more about NSF QP training courses here
