GDP – Certification of good distribution practices

According to the Guide on Good Distribution Practices (GDP) for medicines for human use adopted by the European Commission (EC) in 2013 (2013/C 343/01), the wholesale distribution of medicines is an important activity in the integrated management of the supply chain. According to Article 1 point 17 of Directive 2001/83/EC, the wholesale distribution of medicines means "all the activities of procuring, holding, supplying or exporting medicines, with the exception of the activity of releasing them to the population. These activities are carried out by manufacturers or their warehouses, importers, other wholesale distributors or by pharmacists and persons authorized or entitled to issue medicines to the population of the Member States concerned". Any person acting as a wholesale distributor must hold a wholesale distribution permit. Article 80 letter (g) of Directive 2001/83/EC stipulates that distributors must comply with the principles and guidelines regarding Good Distribution Practices. Holding a manufacturing authorization includes authorization to distribute the medicinal products covered by that authorisation. Manufacturers carrying out any type of distribution activities of their own products must therefore comply with 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.

The quality management system implemented by the medicine supply chain organization must demonstrate that:

medicines are procured, held, supplied or exported in compliance with GDP requirements;

management responsibilities are clearly specified;

the products are delivered to the appropriate recipients within a satisfactory time frame;

recordings are made in real time;

deviations from established procedures are documented and investigated;

appropriate corrective and preventive actions (known as CAPA) are implemented to correct and prevent deviations in accordance with the principles of quality risk management.


The certification scheme for GDP assesses the conformity of the quality management system and the observance of good distribution practices along the entire supply chain, from purchase to transport to the end user.

Third party audit for GDP evaluates the compliance and effectiveness of the system implemented by the organization from the point of view of the requirements of the CE Guide on Good Distribution Practices, requirements relating to:
– the quality management system;
- staff competence and hygiene;
- premises and equipment;
– documentation;
– operational control;
- control of non-compliant outputs and handling of complaints (complaints, returns, drugs suspected of being falsified and withdrawn drugs).
– control of outsourced processes;
– the self-inspection process;
– the transport process