
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
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.
Business consulting for German pharmacies: wholesale terms, digital quality management, valuation and succession. From data review to implementation. Pharmacy Consulting in Germany: Procurement, QMS & Sale →

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
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
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
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
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
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
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
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