Your Questions, Answered

The Responsible Person (fachtechnisch verantwortliche Person – FvP) is the individual legally accountable for ensuring that pharmaceutical activities comply with applicable Swiss regulatory and GxP requirements, including GMP and GDP.

The RP/FvP acts as the official regulatory contact for Swissmedic, representing the company in quality and compliance matters and ensuring that regulatory expectations are clearly understood, implemented, and maintained.

Beyond formal compliance, the RP/FvP is a trusted partner to company management, supporting informed decision-making and safeguarding the organization’s regulatory credibility and reputation through consistent, transparent, and proportionate quality governance.

Yes. In Switzerland, pharmaceutical trading activities are regulated and generally require a Swissmedic license, which includes the appointment of a Responsible Person (fachtechnisch verantwortliche Person – FvP).

This requirement applies even when medicinal products do not physically pass through Switzerland. Under Swiss regulation, activities such as purchasing, selling, brokering, or otherwise placing medicinal products on the market from a Swiss legal entity are considered regulated activities, regardless of physical product flow.

Switzerland’s regulatory framework is distinctive in its scope and depth. It is designed to ensure clear accountability at the legal-entity level, prevent illegal or unauthorized trading, and reduce the risk of falsified medicines entering legitimate supply chains. At the same time, Swiss authorities fully recognize Switzerland’s role as an international business and tax hub, where companies may establish Swiss affiliates for legitimate strategic and financial reasons.

The regulatory model is therefore not intended to challenge these business structures, but to ensure that appropriate quality governance and regulatory oversight are in place alongside them.

In this context, the RP/FvP acts as the official regulatory contact for Swissmedic, representing the company in quality and compliance matters and ensuring that regulatory expectations are clearly understood and appropriately addressed. For company management, the RP/FvP is a key partner in supporting sound decision-making and protecting the organization’s regulatory credibility and reputation.

With an experienced RP/FvP and a proportionate Quality System in place, these requirements can be implemented pragmatically and efficiently, providing companies with the clarity and serenity needed to operate confidently while remaining fully compliant.

Common GDP inspection findings most often relate to governance, oversight, and alignment between documented systems and actual operations, rather than to the absence of procedures alone.

Typical observations include:

• insufficiently defined or inadequately implemented RP/FvP delegations, resulting in unclear accountability and limited effective oversight,

• gaps in oversight of suppliers and customers, particularly where qualification, monitoring, or quality agreements do not fully reflect the realities of the supply chain,

• misalignment between the licensed scope of activities and how trading or distribution activities are performed in practice, and

• weaknesses in deviation management, temperature excursion handling, and risk-based decision-making.

These findings are frequently linked to an incomplete or fragmented understanding of the end-to-end supply chain. A clear and accurate supply chain mapping—covering products, flows, partners, decision points, and responsibilities—is therefore a critical foundation for GDP compliance and inspection readiness.

Prevention relies on establishing a proportionate GDP Quality System that reflects the company’s real operating model, supported by:

• clearly defined RP/FvP responsibilities and delegations,

• appropriate and risk-based oversight of both suppliers and customers, and

• a licensed scope that accurately mirrors actual activities.

When these elements are in place, GDP compliance becomes sustainable and transparent, and inspections focus on confirming effective governance rather than identifying gaps. This approach provides both regulators and company management with confidence that trading activities are well controlled, compliant, and credible.

The Qualified Person (QP) and the Responsible Person (RP) are distinct regulatory roles with different scopes of responsibility under GMP and GDP, although they work closely together across the product lifecycle.

Under GDP, the Responsible Person (RP) is accountable for the effective governance of pharmaceutical trading and distribution activities. This includes oversight of the GDP Quality System, supplier and customer qualification, supply chain integrity, deviation and risk management, and ensuring that licensed activities accurately reflect how operations are performed in practice. Across both the EU and Switzerland, the GDP RP acts as the company’s official regulatory contact for distribution-related compliance matters and inspections.

In Switzerland, the RP role may extend beyond a pure GDP scope and can also include GMP-related responsibilities, depending on the company’s authorization and operating model. In such cases, the RP may have oversight of manufacturing or market-release activities, including governance of release processes, alignment between GMP and GDP requirements, and assurance that products are released in accordance with regulatory and license conditions before being placed on the market.

The Qualified Person (QP), by contrast, has a legally defined responsibility under GMP for the certification and release of individual batches of medicinal products. The QP confirms that each batch has been manufactured, tested, and documented in compliance with GMP and the applicable marketing authorization before it is released for sale or distribution.

A closely related role is that of the Marketing Authorization Holder (MAH), which carries overall responsibility for the medicinal product throughout its lifecycle. In practice, there are important interfaces and areas of overlap between the MAH, QP, and RP—particularly in areas such as product quality oversight, release decisions, distribution arrangements, and regulatory commitments. One of the most common inspection challenges arises when responsibilities between MAH, QP, and RP are not clearly defined or effectively coordinated.

Clear role definition, appropriate delegation, and close collaboration between the QP, RP, and MAH are therefore essential to ensure regulatory compliance, inspection readiness, and consistent, credible decision-making across GMP, GDP, and market-facing activities.

An effective GMP/GDP gap assessment is a risk-based and context-driven evaluation of how well a company’s Quality System, licenses, and operations align with applicable regulatory requirements and inspection expectations.

Rather than relying on generic checklists, a meaningful assessment starts with an understanding of the company’s operating model, supply chain, licensed activities, and regulatory exposure. This allows gaps to be assessed not only against written requirements, but against how the organization actually functions in practice.

Typical deliverables include:

• a clear and prioritized overview of identified gaps, aligned with regulatory and inspection risk,

• an assessment of license scope versus actual activities, highlighting areas that may require clarification or adjustment,

• identification of governance, oversight, or role-definition weaknesses (for example at RP, QP, or MAH interfaces), and

• a practical remediation roadmap, defining actions, responsibilities, and realistic timelines.

Importantly, the outcome is not just a list of deficiencies, but a structured and proportionate action plan that supports inspection readiness and sustainable compliance. The focus is on enabling informed decision-making, avoiding unnecessary complexity, and ensuring that remediation efforts are aligned with both regulatory expectations and business priorities.

When conducted this way, a gap assessment becomes a tool for clarity and confidence, helping organizations understand where they stand, what matters most, and how to move forward efficiently toward compliance and inspection readiness.

A GDP-compliant Quality System is a governance framework that ensures pharmaceutical trading and distribution activities are controlled, transparent, and aligned with regulatory requirements throughout the supply chain.

At its core, an effective GDP Quality System includes:

• clear definition of roles and responsibilities, including the Responsible Person and appropriate delegations,

• accurate oversight of the supply chain, covering suppliers, customers, and service providers based on risk,

• procedures and documentation that reflect how activities are actually performed in practice,

• management of deviations, complaints, and temperature excursions, supported by risk-based decision-making, and

• training and awareness, ensuring that relevant teams understand their GDP responsibilities.

Importantly, a compliant system is not defined by the volume of documentation, but by its effectiveness and proportionality. The Quality System should be tailored to the company’s operating model, licensed activities, and supply chain complexity, while providing sufficient structure to ensure inspection readiness.

When these elements are well aligned, the GDP Quality System becomes a practical tool for daily operations, enabling consistent compliance, clear accountability, and confidence during regulatory inspections.

Supply chain mapping is the structured identification and documentation of how medicinal products move through the end-to-end supply chain, including all involved entities, physical and virtual flows, decision points, and quality responsibilities.

From a regulatory perspective, supply chain mapping is a foundational expectation for both the Responsible Person (RP) and the Qualified Person (QP). It supports effective oversight of trading, distribution, and release activities and underpins key principles such as clear accountability, traceability, and controlled product flow across the product lifecycle.

In practical terms, an effective supply chain map clarifies:

• which legal entities are involved in purchasing, selling, releasing, storing, or transporting products,

• how orders, shipments, and releases are executed in operational systems (for example ERP order flows and shipment lanes),

• whether all transport routes and logistics setups are adequately qualified and controlled, and

• whether each entity involved holds the appropriate authorizations in line with Health Authority requirements.

While supply chain mapping is often perceived primarily as a compliance requirement, its real value lies in enabling a right-first-time setup of systems, licenses, and operating models. When established early and maintained over time, a clear supply chain map allows quality, supply chain, regulatory, and business teams to design and implement processes that are aligned with regulatory expectations from the outset, rather than corrected later through remediation.

From an inspection standpoint, many findings arise not from missing procedures, but from discrepancies between documented processes and actual operating models. A clear and accurate supply chain map enables both the RP and QP to exercise meaningful oversight, explain responsibilities confidently, and demonstrate that quality governance is embedded in daily operations.

When used effectively, supply chain mapping becomes a practical decision-making tool, supporting compliant market release, controlled distribution, and inspection readiness—while giving organizations the clarity and serenity needed to operate complex supply chains with confidence.

Yes. Acting as a transitional or fractional Responsible Person (RP) is a well-established and effective model in Switzerland, particularly for companies at an early stage of development or during periods of transition.

This approach is especially relevant:

• for start-ups or companies preparing their first product launch,

• when a Swissmedic license requires an RP before activities can start,

• when the organization does not yet have the financial capacity to appoint a full-time, experienced RP, or

• when additional time is needed to identify and onboard the right long-term RP who fits both the regulatory requirements and the company culture.

In practice, a transitional or fractional RP provides full regulatory accountability in Switzerland, acting as the official regulatory contact for Swissmedic and ensuring that Quality Systems, supply chain oversight, and decision-making processes are compliant, proportionate, and inspection-ready.

Beyond maintaining compliance, this model supports a structured and sustainable setup. Governance frameworks, delegations, and operating processes can be established in a way that enables continuity, knowledge transfer, and a smooth transition to a permanent RP arrangement when the organization is ready.

When implemented thoughtfully, a fractional RP solution provides regulatory confidence and operational serenity, allowing companies to move forward without delay while ensuring that quality oversight remains robust, credible, and aligned with Swiss regulatory expectations.

Tulia Via reflects both my professional philosophy and my personal roots.

Tulia means serenity in Swahili — a reference to my childhood in Kenya and to the idea of calm, grounded progress.
Via means path or way — a deliberate route forward.

Together, Tulia Via represents a clear and steady path through complexity.

In my work, serenity is not abstract. It is the result of robust, well-designed, and compliant quality systems — systems that work in practice, avoid unnecessary inefficiencies, and stand up confidently to Health Authority expectations.

When processes are clear, fit for purpose, and inspection-ready, teams can focus on their work without constant disruption, last-minute fixes, or regulatory uncertainty. That is the kind of serenity Tulia Via is built to deliver.