GDP – Certification of good distribution practices

According to the Annex "Glossary of terms" to document 2013/C 343/01 of the EC, BPD (GDP) "constitutes that part of quality assurance that guarantees the maintenance of the quality of medicines at all stages of the supply chain, from the manufacturer's premises to the pharmacy or to the person authorized or entitled to supply medicines to the population.”

In the current conditions of the market economy, quality must be considered the strategic key to the competitiveness of products and services on the competitive market, including for organizations in the supply chain of medicinal products for human use. Distribution services must simultaneously fulfill two basic conditions: to be of quality and profitable. Because it plays an essential role in the performance of the modern organization, quality must represent the main concern within the management due to the economic and social implications that are of great depth.

The certification of good distribution practices (GDP) for pharmaceutical products demonstrates the organization's commitment to maintaining quality in all stages and aspects of the services provided and for compliance with good distribution practices.

According to the Guide on Good Distribution Practices (GDP) for medicinal products for human use adopted by the European Commission, wholesale distributors must have a quality system through which responsibilities, procedures and risk management principles are established for the activities they carry out. All distribution activities must be clearly defined and systematically analyzed. All critical stages of distribution processes and all significant changes must be justified and, where appropriate, validated. The quality system is the responsibility of the organization's management, assuming its first involvement and active participation, and must be supported by the commitment of the staff.