What does GDP mean?
GDP means Good Distribution Practice. EU guidelines 2013/C 343/01 address wholesale distribution of human medicines. A building alone cannot deliver compliance: the operator must control how medicines are received, stored, checked and supplied.
From space requirements to an operating model
Start with the product portfolio and intended activities. Temperature requirements, stock levels, throughput and stock status shape the layout. Include receiving, blocked stock, picking and dispatch areas. Equipment, staffing and evidence can then be planned for the actual operation.
Distinguish GDP, authorisation and GMP
GDP sets distribution requirements. A wholesale distribution authorisation permits the activities within its scope. A GDP certificate records the outcome of an authority inspection. Manufacturing and certain packaging operations may additionally require GMP and a manufacturing authorisation. The actual activity determines the requirements.
Cheb within your supply chain
Plan the Czech warehouse operation together with supplies to your target markets. Identify the operator, competent authority, carriers, working languages and contacts. Your enquiry should describe temperature zones and goods flows as clearly as floor area and the intended start date.
Prepare for site planning
The planning lists below are practical recommendations for your site project; they do not replace project-specific qualification or a regulatory decision.
- Define product groups and activities
- Record temperature requirements and peak stock
- Identify the operator and responsible person
- Connect layout, quality system and authorisation pathway
- Set realistic qualification and start-up milestones