Although it is considered elemental to have established unified Policies regarding Pharmaceutical Products’ Best Manufacture and Distribution, the latter came into force via the GDPs Legislation in November 2013, thus substituting former Policies existing since 1994.
The new GDPs’ target was to introduce new Guidelines which were published by the EU Committee regarding the best practice on Pharmaceuticals Distribution within the EU dominion. These new GDPs Guidelines featured a number of Reformations of pivotal importance which were considered imperative in order to constitute the new venture as a step towards the right direction:
- Introduction of a new Quality Management System, which includes Risk Management and Assessment regarding the Pharmaceuticals’ Preservation of Quality and Integrity Characteristics.
- Investment on experienced Staff possessing the appropriate status and qualifications to support the new Concept as well as to execute the new Protocols and Processes.
- Utilization of appropriate and suitable infrastructure and relative apparatus to accommodate the best storing and transportation of Pharmaceuticals.
- Documentation in written form in order to avoid mistakes/ adequacies spearheaded by verbal communication, whereas at the same time there is the ability to have traceability of all relevant actions regarding the transportation of Pharmaceuticals through the constitution and conservation of records.
- Suppliers’, Agents’ and Customers’ Evaluation
- Constitution of specialized Protocols concerning Complaints, Pharmaceutical Products’ Recalls, Falsified Pharmaceutical Products’ Detection and Withdrawal.
- Contracts Constitution covering all areas/actions undertaken by Third Parties in order to minimize the possibility of misunderstandings which could possibly affect the Pharmaceuticals Products’ Quality and Integrity Characteristics.
- Transportation and Distribution Specifications for Pharmaceuticals, Medicines featuring specific claims for thermo-sensitive pharmaceutical products.
- Constitution of Specifications and Guidelines for Pharmaceuticals’ Exports in Countries of the rest of the World.
- Special Provisions for Agents.