Good Distribution Practice (GDP)
What Is Good distribution practice (GDP):
Good distribution practice (GDP) is the term that describes the minimum standard a wholesale distribution company is required to adhere to which ensures quality, integrity and standards of medicines are maintained throughout the supply chain.
Why Is GDP Compliance Essential:
1. Medicines in the supply chain are authorised in accordance with European Union (EU) legislation;
2. Medicines are stored in the right conditions at all times, including during transportation;
3. Contamination by or of other products is avoided;
4. Adequate turnover of stored medicines takes place;
5. The right products reach the right addressee within a satisfactory time period.
The distributor should also put in place a tracing and reporting system to enable finding faulty products and an effective recall procedure.
Good Distribution Practice (GDP) also applies to the sourcing, storage and transportation of active pharmaceutical ingredients and other ingredients used in the production of the medicines.
Wholesale distribution authorisation:
Anyone engaged in the activity of wholesale distribution of medicinal products in the EEA must hold a wholesale distribution authorisation issued by the national competent authority of the Member State where they carry out these activities. The same national authority is responsible for inspecting the wholesale distributor.
Wholesale distributors must comply with EU GDP to obtain a wholesale distribution authorisation. They can ensure that they meet all their legal obligations by following the GDP guidelines.
Manufacturing authorisation holders do not require a separate authorisation to distribute products that are already subject to a manufacturing authorisation.
Importers and distributors of active substances intended for the manufacture of medicines in the EEA are obliged to register with the relevant national competent authority and comply with the principles of GDP for active substances.
Parallel distributors also must comply with GDP.
EudraGMDP is a publicly accessible EU database containing all wholesale distribution authorisations and details of registered importers and distributors of active substances in the EEA.
After inspecting a wholesale distributer, EU competent authorities issue a GDP certificate or a non-compliance statement, which is entered in the EudraGMDP database.
EudraGMDP also contains information relating to good manufacturing practice (GMP).
The range of Procuro solutions allow Pharma companies with the Good Distribution Practice (GDP).
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