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Good Distribution Practice (GDP) is a quality standard for the supply, procurement, storage, and export of pharmaceuticals.
GDP ensures that pharmaceutical wholesalers must always follow the same quality requirements to safeguard the quality and integrity of pharmaceuticals throughout the whole supply chain. Wholesaler distributors with a GDP license are inspected against the European GDP guideline and local regulations by governments.
When a wholesaler distributor has been inspected by the government and meets the GDP regulations, the government will issue a GDP license and GMP certificate.
Which requirements do you have to meet for GDP certification in EU?
In order to meet the requirements for a GDP license in an EU country, a company must meet a number of requirements. At PharmaGroup, we have specialized experts in obtaining a GDP license who can support you with all the initial tasks including:
Completion and submission GDP license application along with relevant documentation to the local health authority
Implementation of Quality Management System in accordance with Good Distribution Practice (GDP) in EU and local legislation. We will help you to establish and implement all relevant processes, including.
- Instructions, SOPs and Quality Manual
- Job descriptions and organization chart
- Training documentation for all employees
- Quality agreement with GDP service providers and contractors
- Change control and deviation management
- Customer complaints and recalls
- Qualification and oversight of GDP service providers
- Qualification of customers and suppliers
- Quality Management Review
- Audits and self-inspections
- Management of returned products
- Handling of falsified medicines
- Good Documentation Practice
- Quality Risk Management
- Distribution complaints
- Shortage management
- Goods receipt and release process