EU GMP: 5 Essential Personnel Requirements You Might not know
- Riccardo Longato
- Jan 5
- 6 min read
Updated: 6 days ago
The role of senior management in the quality system
While many organizations view the Head of Quality as the final authority on the quality system, EU GMP places the "ultimate responsibility" squarely on senior management. Their role extends far beyond funding the quality department; they must actively ensure the entire quality management system is effective and that all roles are clearly defined and implemented.
Senior management has the ultimate responsibility to ensure an effective quality management system is in place to achieve the quality objectives, and, that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation.
This mandate represents a paradigm shift, elevating quality from a departmental function to a core, C-suite-level business strategy. To make this responsibility tangible, the guidelines require senior management to establish the company's formal "quality policy" and to personally ensure its effectiveness through active "participation in management review."
Independence between Production and Quality Control
The guidelines are unequivocal: the heads of the Production and Quality Control departments must be independent of each other. This is a non-negotiable structural requirement detailed in section 2.5 of the guidelines.
This structural firewall is vital because it prevents a scenario where the intense pressure to meet a production quota could influence or override the QC Head's impartial, data-driven decision to reject a substandard batch of materials or a finished product. It ensures that the authority to approve or reject remains objective and uncompromised.
Responsibilities of the Qualified Person (QP) in batch certification
The role of the Qualified Person (QP) carries a profound level of personal and legal accountability. The QP must personally ensure and certify that every single batch of medicine has been manufactured and checked in compliance with all relevant laws and the product's marketing authorization.
For products imported from outside the EU, the requirements become even more stringent. The QP must ensure each batch has undergone, within a Member State, a "quantitative analysis of at least all the active substances" and "all the other tests or checks necessary" to confirm its quality. Crucially, the QP must then personally "certify in a register or equivalent document" that the batch complies before it can be released, making their personal and professional burden central to the EU's drug safety framework.
Mandatory training for all personnel
A frequently overlooked detail is the broad scope of mandatory GMP training. The guidelines require training for all personnel whose work could potentially affect product quality. This explicitly includes not just production operators and lab analysts but also "technical, maintenance and cleaning personnel," as stated in section 2.10.
This proves that from a GMP perspective, quality is only as strong as its weakest link. A single misstep by a maintenance technician during calibration or a cleaner using the wrong sanitizing agent can compromise an entire multi-million euro batch.
Collaboration between QA, QC and Production
Contrary to the common perception of rigid departmental silos, the guidelines mandate significant collaboration. They outline a number of shared responsibilities between the heads of Production and Quality Control, and where a separate Quality Assurance function exists, its head is also jointly responsible. This collaborative framework includes several high-impact duties:
• The approval and monitoring of suppliers of materials
.• Process validation.
• The monitoring and control of the manufacturing environment.
• Ensuring a timely and effective communication and escalation process exists to raise quality issues.
This is not simply a suggestion for good teamwork; it is a mandated regulatory framework. The EU GMP guidelines architect an organizational structure where quality oversight is interwoven into the fabric of operations, not bolted on at the end.
Is Your Organisation Fully Aligned With EU GMP Personnel Requirements?
Ultimately, EU GMP compliance is about architecting an organization for quality, from C-suite accountability and mandated departmental independence to the profound personal responsibility of the QP and the integrated, cross-functional ownership of quality processes. Does your current organizational chart truly support these principles, or does it create invisible barriers to quality?
Take the Next Step
Ready to ensure your personnel structure and processes are fully aligned with GMP principles? Contact one of our experts to review your processes and optimize them.
What are the core personnel requirements under EU GMP?
EU GMP Chapter 2 sets out the fundamental personnel expectations: qualified staff, clear responsibilities, independence where required, training, and documented authority, all essential to ensure compliance and product quality.
Why must production and quality control be independent?
Independence ensures that quality decisions are not influenced by production pressures. EU GMP requires that the head of Production and the head of Quality Control must be organisationally separate to prevent conflicts of interest.
Who is a Qualified Person (QP) and why are they essential?
A Qualified Person is legally responsible for certifying that batches are manufactured and checked according to GMP and the Marketing Authorization. Their role is defined in Article 51 of Directive 2001/83/EC and detailed in EU GMP Annex 16.
Does EU GMP require documented job descriptions for all roles?
Yes. Each key role must have a written job description outlining responsibilities and authority. Clear documentation prevents gaps or overlapping duties that could compromise compliance.
Is GMP training mandatory for all personnel?
Yes. All personnel must receive initial and ongoing GMP training relevant to their responsibilities, including hygiene, safety, documentation practices and quality risk awareness.
Can a single person perform multiple key roles?
Only if there’s no risk to product quality and responsibilities are clearly documented. However, EU GMP emphasises adequate staffing and authority segregation to safeguard compliance.
What happens if personnel requirements are not met?
Failure to meet personnel requirements often leads to regulatory findings, warning letters, import alerts or even suspension of manufacturing licences because personnel competence is fundamental to GMP compliance.
Why are personnel requirements vital for patient safety?
Qualified and trained personnel ensure that processes are executed correctly, deviations are properly investigated and GMP principles are maintained, directly protecting the end patient from substandard medicines.
About the Author
Riccardo Longato is an Italian entrepreneur, former ISO 9001 Auditor with a background in quality management systems implementation and quality assurance in the pharmaceutical industry. In 2023, together with his brother Fabrizio Longato, he co-founded Clear S.r.l. Benefit Corporation, a company that combines technical expertise and ethical vision to help businesses and institutions build solid, transparent compliance infrastructures in highly regulated sectors such as the medical cannabis industry, providing certification, quality assurance, and compliance support services.
Before founding Clear, Riccardo worked as an independent consultant, assisting companies of various sizes in developing management systems aligned with ISO standards. His approach is grounded in the belief that regulation should not be seen as bureaucracy, but as a tool to foster clarity, accountability, and lasting trust.
With Clear, Riccardo contributed to the creation of the Clear Certification Standard (CCS™), a globally recognized international certification model dedicated to ensuring the quality of pharmaceutical raw materials. Today, Clear works with producers, pharmaceutical companies, and regulatory authorities to ensure traceability, data integrity, and product quality, from cultivation to the patient.
In Italy, Riccardo also serves as Managing Partner of Clear Italia, supporting companies and organizations in developing management systems, structured financing initiatives, and modern governance models. His mission is to transform compliance obligations into strategic pathways for growth and transparency.
Active internationally, Riccardo also participates as a speaker and contributor in discussions on the future of medical cannabis, advocating for ethical, safe, and patient-centered supply chains that strengthen responsible enterprises.
Official References
European Commission – EudraLex Volume 4: EU GMP Guidelineshttps://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_enThe official collection of European Union Good Manufacturing Practice (GMP) guidelines governing pharmaceutical manufacturing, quality systems and regulatory compliance.
EU GMP Chapter 2 – Personnelhttps://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_enChapter 2 of EudraLex Volume 4 defines the regulatory requirements for pharmaceutical personnel, including responsibilities, organisational structure, training, hygiene and independence of functions.
Directive 2001/83/EC – Article 51 (Qualified Person)https://eur-lex.europa.eu/eli/dir/2001/83/ojThe European medicines directive establishing the legal responsibility of the Qualified Person (QP) for certifying each pharmaceutical batch before it is released to the EU market.
EU GMP Annex 16 – Certification by a Qualified Person and Batch Releasehttps://health.ec.europa.eu/system/files/2016-11/annex16_en.pdfAnnex 16 of the EU GMP Guidelines defining the detailed obligations, authority and certification process performed by the Qualified Person prior to batch release.
European Medicines Agency (EMA) – Good Manufacturing Practice (GMP) Overviewhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practiceThe official EMA page describing GMP principles, inspections and regulatory expectations across the European pharmaceutical sector.
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