Good distribution practice (GDP) is a quality system for warehouses and distribution centres that handle medicines. GDP covers the movement of finished products from manufacturing sites to wholesalers, retailers and patients. The European Union added a GDP requirement in 2013 for a supply chain, from raw materials to the final product, due to increased globalization, the sensitivity of certain therapeutic drug ingredients and stricter controls to maintain the quality and integrity of medicinal products.
For companies involved in the procurement, storage and transportation of active pharmaceutical ingredients and other ingredients for pharmaceutical production and companies involved in the distribution of finished products to the final consumer, the implementation of GDP is a key tool to ensure patient safety, maintain quality and integrity of medicinal products.
Wholesale distribution of medicinal products is an important activity in integrated supply chain management. The distribution network for medicinal products is becoming increasingly complex and involves many actors. The GDP establishes tools to assist wholesale distributors in carrying out their activities and to prevent falsified medicinal products from entering the supply chain.
 
What is good distribution practice?
The Good Distribution Practice is a set of requirements regarding the supply, processing, storage and transportation of medicines for human use and their active ingredients. Holders of wholesale licenses and marketing authorisation of medicinal products must comply with good distribution practice.
 
Why is good distribution practice important?
GDP aids product traceability, which can be a huge factor in formal investigations of quality issues or incidents involving pharmaceuticals. Adherence to good distribution practices protects wholesale distributors from situations that would not only harm their reputation, but also harm the end user of medical products and result in a huge loss of customers.
 
Who needs GDP certification?
According to the European Medicines Agency, all wholesale distributors of medicines in the European Economic Area need a GDP certificate. In the European Union, the GDP certificate is issued by a competent authority of a member state.
 
What are the areas of focus according to GDP
1. Wholesale distributors must maintain a quality system defining responsibilities, processes and risk management principles related to their activities. The quality system must follow the organizational structure, procedures, processes, resources and actions necessary to demonstrate that the quality and integrity of the delivered product is maintained and remains within the legal chain of supply during storage and/or transport. Distributors are required to assess potential product quality risks and follow quality risk management principles.
2. At all stages of the activities of wholesale distribution of medicinal products, there should be a sufficient number of staff with relevant competence, which is constantly maintained. Management must appoint a responsible person whose duties include implementing and maintaining the quality system and all activities necessary to comply with GDP.
3. Wholesalers should investigate whether a potential supplier has a wholesale distribution permit or wholesaler license before selecting them. Also, wholesalers must only accept orders from customers with wholesale distribution permits, trade licenses or are authorized to supply drugs.
4. Warehouses must be clean, dry, and pest-free, and must have measuring devices to ensure that appropriate storage conditions, such as temperature and humidity, are maintained. Medicinal products should be handled and stored in such a way as to prevent spillage, breakage, contamination and mixing.
5. The wholesale distributor is responsible for protecting the medicinal products from breakage, counterfeiting and theft, as well as for ensuring that temperature conditions are maintained during transportation. Regardless of the method of transport, the distributor must be able to prove that the medicinal products have not been exposed to conditions that could impair their quality and integrity. A risk-based approach should be used when planning transport. During transportation, the necessary conditions for the storage of medicinal products must be maintained within the limits specified by the manufacturer.
6. Documentation must be sufficient to allow full traceability of medicinal products through distribution channels. All actors in the supply chain must be easily identifiable.
7. Complaints, returns, recalls. Complaints fall into two categories: (1) those related to the quality of the product and (2) those related to its distribution. For quality complaints, the distributor must immediately inform the manufacturer or the holder of the manufacturing authorization. For distribution complaints, the distributor must conduct an investigation to determine the cause of the problem stated in the complaint.
In the event of a recall, the wholesaler must inform the following stakeholders in the supply chain:

8. Counterfeit drugs and pharmaceutical products. The distributor is obliged to immediately notify the competent authority and the holder of the authorization for use when identifying or suspecting that the medicinal product is falsified.
When a pharmaceutical product is confirmed to be counterfeit, a formal decision must be made by the distributor regarding its disposal. The distributor is required to take steps to ensure that counterfeits do not re-enter the supply chain or mix with salable stock.
9. Self-inspections – a key requirement for good distribution practice is a self-inspection program. The scope of the self-inspection may vary. The wholesaler decides on the period and scope of the self-inspections. The results should be recorded in a report. Corrective and preventive actions should also be documented.
 
Instead of a conclusion
Managing the quality of medicines during distribution is a challenging operation. Challenges to the pharmaceutical supply chain are due to defined shelf life and storage conditions. Good distribution practices ensure that the safety and quality of medicinal products are maintained during distribution along the supply chain, and this practice is of great importance to the pharmaceutical industry. The CONSEJO team consults and supports the process of obtaining a GDP certificate and implementing good distribution practices in a comprehensive quality management system.