EU GMP Chapter 1: 4 strategic principles for a modern PQS
- Riccardo Longato
- Jan 4
- 7 min read
Updated: 6 days ago
What is EU GMP Chapter 1?
For many Good Manufacturing Practice (GMP) is seen as a dense set of operational rules, a compliance checklist owned by the quality department. While this operational focus is vital, it obscures a much larger strategic reality. But lurking within its opening chapter are foundational principles that, when understood, transform the Pharmaceutical Quality System (PQS) from a cost center into a strategic asset for managing risk and driving continual improvement.
The foundational document, EudraLex Volume 4, Chapter 1, outlines a far more dynamic philosophy of quality. It deliberately uses the term “Pharmaceutical Quality System” to align with the modern concepts of ICH Q10, a term used interchangeably with the older “pharmaceutical quality assurance system.” This framework extends from the boardroom to the global supply chain, treating quality not as a final inspection gate but as a proactive, integrated business system.
This article uncovers four of the most impactful and perhaps counter-intuitive principles from Chapter 1. Understanding these truths is critical for any organization aspiring to move beyond mere compliance and build a genuine, resilient culture of quality.
Ultimate responsibility: quality starts in the C-suite
Contrary to common belief, the ultimate responsibility for an effective Pharmaceutical Quality System (PQS) does not rest with the Head of Quality, it resides squarely in the C-Suite. The GMP guidelines are unequivocal in placing this accountability at the highest level of leadership, making quality a core function of corporate governance.
Section 1.5 leaves no room for ambiguity, stating that senior management must ensure the PQS is adequately resourced and that their leadership and participation are non-negotiable:
“Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place, adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Senior management’s leadership and active participation in the Pharmaceutical Quality System is essential.”
This C-suite ownership is the bedrock of a resilient quality system, directly influencing budget allocation for new technology, protecting the quality unit from undue commercial pressure, and ultimately safeguarding the company’s license to operate. It ensures that quality objectives are woven into the fabric of the business, promoting a culture where patient safety and product efficacy are never compromised.
Beyond human error: systemic analysis of deviations
While “human error” is a common conclusion in deviation investigations, EU GMP Chapter 1 explicitly challenges it as a sufficient root cause. The guidelines demand a much more rigorous and system-oriented approach, pushing organizations to look beyond individual actions and examine the environment in which they occur.
Section 1.4 (xiv) instructs that where human error is suspected or identified as the cause, this conclusion must be justified. Crucially, investigators must first take care to ensure that:
process, procedural or system-based errors or problems have not been overlooked.
The regulation reinforces this by stating that the level of root cause analysis “can be determined using Quality Risk Management principles.”
This principle shifts the focus from blaming individuals to strengthening the systems that support them. Was the procedure ambiguous? Was the training insufficient? Is the process design prone to failure?
By mandating a systems analysis first, the regulation drives the implementation of effective Corrective and Preventive Actions (CAPAs) that prevent recurrence and foster genuine process control and operational efficiency.
Quality across the entire product lifecycle
Another common misconception is that GMP applies only within the walls of the manufacturing plant. Chapter 1 demolishes this narrow view, defining a PQS that extends across the entire product lifecycle and its global supply chain, ensuring comprehensive oversight from concept to discontinuation.
The temporal scope of the PQS, outlined in section 1.2, is vast. It applies to:
• investigational medicinal products
• technology transfer
• ongoing commercial manufacturing• product discontinuation
Simultaneously, the PQS’s organizational scope extends far beyond the company’s direct control.
Section 1.4 mandates robust processes for:
• supplier selection and monitoring
• management of outsourced activities
• correct starting and packaging material control
This lifecycle-based view transforms GMP from a factory-focused inspection regime into a comprehensive supply-chain risk management strategy, from API sourcing to post-market surveillance.
A system in motion: the mandate for continuous improvement
A PQS is not a static set of documents filed away after an audit. Chapter 1 establishes it as a living, dynamic system designed to drive continuous improvement.
Section 1.4 (xi) states that the PQS must facilitate:
continual improvement through the implementation of quality improvements.
This mandate is operationalized through two key mechanisms:
Management review and Product Quality Review
Section 1.6 requires periodic management review where leadership evaluates PQS performance and improvement opportunities.
Product Quality Review (PQR)
Section 1.10 requires:
regular periodic or rolling quality reviews of all authorised medicinal products
to verify process consistency and identify improvements.
Section 1.11 clarifies that both the manufacturer and the marketing authorization holder must evaluate the results, reinforcing shared accountability.
These mechanisms ensure the PQS evolves rather than stagnates, continually strengthening product quality and risk control.
Conclusions and next steps
EU GMP Chapter 1 is far more than a rulebook. It is a strategic blueprint for a sophisticated, top-down, and dynamic approach to pharmaceutical quality.
By:
• placing ultimate responsibility on senior management
• demanding investigation beyond “human error”
• extending scope across the full lifecycle
• mandating continual improvement
the regulation provides a framework for building a truly effective quality culture.
Understanding these core principles is the first step toward achieving a state of control that is proactive, resilient, and embedded from the C-suite to the supply chain.
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What is EU GMP Chapter 1?
EU GMP Chapter 1 is the section of the European Union Good Manufacturing Practice guidelines that defines the Pharmaceutical Quality System (PQS) shifting quality from a compliance checklist into a strategic system spanning the entire product lifecycle.
Who is responsible for the Pharmaceutical Quality System under EU GMP?
Under EU GMP Chapter 1, ultimate responsibility for the PQS lies with senior management, not only the Quality Assurance department. Company leadership is accountable for quality performance, resources and risk control.
What is a Pharmaceutical Quality System (PQS)?
A PQS is the integrated system that manages product quality, regulatory compliance, risk management, supplier control, change management and continuous improvement across the full pharmaceutical supply chain.
How does EU GMP Chapter 1 go beyond traditional quality control?
Chapter 1 requires quality to be built into business governance, not just verified by testing. It includes management review, risk-based decision making, lifecycle oversight and structured improvement processes.
Does EU GMP Chapter 1 apply to small and medium-sized companies?
Yes. EU GMP Chapter 1 applies to all pharmaceutical manufacturers, regardless of size. Smaller companies must scale their systems, but governance, accountability and risk control remain mandatory.
What is continuous improvement under EU GMP?
Continuous improvement means the PQS must actively evolve using product quality reviews, trend analysis, corrective actions, and management oversight to reduce risk and increase product reliability over time.
Does the PQS cover outsourced manufacturing and suppliers?
Yes. EU GMP Chapter 1 requires full control over outsourced activities and suppliers. The marketing authorisation holder remains responsible for quality even when manufacturing is subcontracted.
Why is EU GMP Chapter 1 critical for patient safety?
Because it ensures that medicines are designed, produced, monitored and improved using scientific risk management and leadership accountability, preventing quality failures that could harm patients.
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.
Riferimenti normativi ufficiali
European Commission – EudraLex Volume 4: EU GMP Guidelineshttps://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_enLa raccolta ufficiale delle linee guida di Good Manufacturing Practice (GMP) vigenti nell'Unione Europea. Volume 4 contiene i principi generali e i requisiti applicabili alla produzione farmaceutica, incluso il Capitolo 1 sul Pharmaceutical Quality System.
EU GMP Chapter 1 – Pharmaceutical Quality System(Link diretto all’EudraLex Volume 4 che include il Capitolo 1)https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_enIl Capitolo 1 del Volume 4 di EudraLex definisce il sistema di qualità farmaceutico (PQS) e le aspettative regolatorie di gestione, responsabilità, rischio e miglioramento continuo.
EMA – Good Manufacturing Practice (GMP) Overviewhttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practicePagina ufficiale dell’European Medicines Agency che introduce i principi e le aspettative di GMP nell’Unione Europea, inclusi riferimenti ai principali capitoli normativi come il Chapter 1.
ICH Q10 – Pharmaceutical Quality System (Internazionale)https://database.ich.org/sites/default/files/Q10_Guideline.pdfLinee guida internazionali sul Quality System farmaceutico riconosciute in UE, US e Giappone. Anche se non è una norma UE, costituisce riferimento internazionale spesso richiamato da EMA e GMP inspectorate.
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