Some issues for implementing the requirements for good practices (GxP). Good distribution practice (GDP) (Part 3)

Abstract

Aim. To conduct a detailed study of the requirements of good distribution practice.

Materials and methods. The analysis of the current Guidelines on good practices (GxP), in particular the Guideline ST-N 42-5.0:2014 of the Ministry of Health of Ukraine “Medicines. Good Distribution Practice” was performed. Interpretations for implementing the requirements of good distribution practice based on the experience of conducting audits of distribution companies for compliance with the GDP requirements were proposed.

Results and discussion. The competencies of other personnel involved in the distribution of medicines, the benefits of using these personnel and the risks that may result from an imbalance between workload and number of the staff have been determined. The need to clearly define the roles, responsibilities and relationships of all employees has been studied. The Responsible – Accounable – Consulted – Informed method is given. The necessity of training for the staff involved in wholesale distribution activities and the risks associated with its absence have been studied. The risks associated with the recruitment of temporary staff have been studied in detail. The stages of organizing the training process for the personnel involved in wholesale distribution activities have been analyzed in detail.

Conclusions. A detailed analysis of the personnel training involved in wholesale distribution activities has been proposed; it will minimize risks and errors that can negatively affect the quality of medicines.