Qualified Person (QP): A Guide to the Key Figure in the European Pharmaceutical Industry

Introduction: The Legal Guarantor of Medicines

In the European pharmaceutical landscape, there is a unique professional figure with unparalleled power and legal responsibility: the Qualified Person (QP) . This role, specific to EU legislation, is not simply a managerial position, but a legal requirement imposed by Directive 2001/83/EC.

The QP is the individual who, with their signature, certifies each individual batch of medicinal product before it can be released onto the market. They are the last bastion of patient safety, assuming personal (and potentially legal and criminal) responsibility for ensuring that the batch is safe, effective, and compliant with both Good Manufacturing Practices (GMP) and the Marketing Authorization (MA).

The Regulatory Basis: Directive 2001/83/EC

To understand the QP, we must start with the law. Directive 2001/83/EC (the "Community Code") defines the role in Articles 48-52.

• Article 48: The Obligation to Have a Qualified Person (QP) Every manufacturer or importer of medicinal products in the EU must have the services of at least one QP "permanently and continuously." Without a QP appointed on the plant authorisation (MIA), the company cannot operate.
• Article 49: Qualification Requirements (How to Become a QP) You can't just improvise as a QP. The law requires a specific combination of academic training and practical experience:
1. Qualification: A degree in a scientific discipline (Pharmacy, CTF, Chemistry, Biology, Medicine, Veterinary Medicine) of at least 4 years.
2. Practical Experience: At least two years of experience in an authorized company, performing qualitative and quantitative analysis and quality control activities. (This duration may be reduced if the degree program is longer, e.g., 5 or 6 years).
• Article 51: Tasks (Certification) This is the core of the QP's responsibility. Before releasing a batch, the QP must certify (in a register) that:

• The batch is GMP compliant.
• The batch complies with the AIC.
• For batches imported from third countries (outside the EU), all necessary analytical tests have been carried out in the EU (except for MRA agreements).

The Sole Responsibility of the QP: Legal, Civil and Criminal

Unlike the QA Manager (who has a managerial responsibility for the system ) or the Quality Unit in the USA (where the responsibility is corporate), the responsibility of the QP in Europe is personal .

If a defective batch causes harm to patients and the QP is found to have certified the batch negligently (e.g., ignoring OOS data, incomplete documentation, or giving in to commercial pressure), the QP may be held liable:

• Administrative Responsibility: The authority (e.g. AIFA) can suspend or revoke the QP's eligibility, preventing him or her from working.
• Civil Liability: QP may be included in damages claims (although usually covered by company insurance).
• Criminal Liability: In cases of intent or gross negligence resulting in injury or death, the QP may face criminal consequences.

This enormous burden of responsibility explains why the QP must act with complete decision-making independence, even against the company's commercial interests.

How to Become a QP: The Real Path

The legal process (Art. 49) is just the beginning.

• National Differences: Academic requirements vary. While Italy accepts various scientific degrees (CTF, Pharmacy, Chemistry, etc.), other countries are more restrictive. In France and Portugal, for example, only pharmacists can become QPs. In the UK (pre-Brexit) and Ireland, the path is open to chemists and biologists but requires passing a formal oral exam (QP panel exam).
• Practical Experience: Although the law speaks of "quality control", it is now widely accepted that experience in Quality Assurance (deviation management, audits) and Production is equally valid, if not essential, to form a complete QP.

FAQ – Frequently Asked Questions about the Qualified Person

Q: What is the difference between a QP and a QA Manager? A: The QA Manager is responsible for the health and compliance of the entire Quality System (procedures, audits, CAPA). The QP has the legal responsibility to certify that every single batch produced by that system is compliant. The QP relies on the QA's work, but the final signature (and legal responsibility) is theirs.

Q: Must a QP be a pharmacist? A: Not necessarily throughout Europe. It depends on the Member State. In Italy, graduates in CTF, Chemistry, and Biology can become QPs. In France, yes, being a pharmacist is mandatory.

Q: What happens if the QP refuses to sign a release? A: The batch cannot be sold or distributed. It remains in quarantine. The QP's decision is final and is intended to protect the patient from a product deemed unsafe or non-compliant.

Conclusion: The Guardian of Security

The Qualified Person is much more than a "signatory." They are highly qualified professionals with a solid scientific and regulatory background, who are entrusted by European law with ultimate responsibility for drug safety. This is a highly pressured role, but also one of enormous strategic value and ethical impact.

To understand in detail the legal obligations, the operational challenges of batch release and how to manage QP responsibility in complex scenarios (imports, deviations), the " Complete Guide to the Qualified Person (QP) Role " by GuideGxP.com is the essential reference.