Service area · Entrepreneurial pharmacy management

Plan, authorise and launch a pharmacy-owned pharmaceutical wholesaler

Plan a pharmacy-owned pharmaceutical wholesaler in Germany: authorisation, GDP QMS, Responsible Person, premises and inspection preparation.

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A pharmacy-owned pharmaceutical wholesaler as a complete operating model

Section 52a AMG · GDP · wholesale authorisation

A pharmacy-owned pharmaceutical wholesaler as a complete operating model

tiger.PHARMA combines the services commonly offered separately in the market – licence support, QMS templates, Responsible Person support and pre-audits – with commercial modelling, facilities, logistics, systems, procurement, customer processes and controlled launch.

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Your assignment: records and assessment

Your assignment: records and assessment

A pharmacy-owned wholesaler is a separate operating model with additional quality and organisational duties. Before setup, we examine products, sourcing, customers, storage and commercial viability. Wholesale responsibilities are distinguished from the pharmacy's existing activities.

  • Business model and planned goods flows
  • Premises, temperature requirements and IT
  • Roles, QMS records and application status
From findings to implementation

From findings to implementation

A project plan covers German authorisation, GDP QMS, the Responsible Person and operational interfaces. Scope is coordinated with the competent authority and relevant specialists before investment in equipment and workflows.

    Feasibility and business case

    Feasibility and business case

    Use cases, assortment, volumes, margin, investment, people and working capital are tested before major spend.

    • Direct purchasing, specialist ranges and partner supply
    • Supplier, customer and volume model
    • Investment, operating cost and working capital
    • Base, target and downside scenarios
    Separation from the pharmacy operation

    Separation from the pharmacy operation

    Roles, stock, contracts, movements, systems and responsibilities are separated while controlled interfaces remain workable.

    • Activity and licence matrix
    • Organisation and responsibility model
    • Separate stock, records and counterparties
    • Conflicts, internal supply and escalation
    Authorisation and authority project

    Authorisation and authority project

    The operating model becomes a structured application and evidence roadmap aligned with the competent authority and authorised advisers; approval cannot be guaranteed.

    • Scope and application documentation
    • Facility, zoning, people and operating concept
    • Milestones and authority communication
    • Readiness review before inspection
    Responsible Person and GDP governance

    Responsible Person and GDP governance

    The RP is embedded early with real authority, resources, deputy arrangements and independent escalation.

    • Role profile, selection and onboarding
    • Delegation and approval matrix
    • Management review and quality KPI
    • Optional search and continuing support
    GDP QMS and controlled documents

    GDP QMS and controlled documents

    A lean, business-specific QMS replaces a disconnected template pack.

    • Quality manual, process map and SOPs
    • Supplier and customer qualification
    • Deviation, CAPA, change, returns and recall
    • Training, self-inspection and document upkeep
    Warehouse, transport and qualification

    Warehouse, transport and qualification

    In-house and outsourced activities form one controlled GDP chain.

    • Layout, quarantine, security and traceability
    • Temperature mapping, monitoring and calibration
    • Route, vehicle and packaging qualification
    • Quality agreements, SLA, audits and partner KPI
    ERP, WMS, MSV3 and data

    ERP, WMS, MSV3 and data

    Master, batch, order and customer data are designed for traceability and scale, then tested end to end.

    • ERP and WMS requirements
    • PZN, master, batch and serialisation data
    • MSV3 ordering and status responses
    • Access, logs, data quality and continuity
    Pre-audit, launch and managed support

    Pre-audit, launch and managed support

    Mock inspections and live process tests bridge documentation and routine operation.

    • GDP gap analysis and mock inspection
    • CAPA and effectiveness evidence
    • Pilot, go-live and hypercare
    • Ongoing QMS, audits, training and change support

    FAQ

    Frequently asked questions

    When does a pharmacy need wholesale authorisation?

    That depends on the planned activities, flows and customers. The boundary between pharmacy activity and authorised wholesale distribution should be clarified early with the competent authority and authorised advisers.

    Can a wholesaler share a building with the pharmacy?

    Any arrangement requires an authority-accepted separation of facilities, stock, processes, records and accountability. The concrete model must be addressed in the facility and operating concept.

    Does tiger.PHARMA only provide an application and SOPs?

    No. Support can cover feasibility, authorisation, QMS, RP, warehouse, transport, systems, qualification, mock inspection, launch and ongoing operation, while remaining modular.