Classification of directions of activity of the pharmaceutical control system

Abstract

Introduction. The activity of the pharmaceutical control system (FCS) is multiaspectual and multidimensional. For these two reasons, in order to carry out an in-depth study of the FCS, it is necessary to systematize the dimensions of the activity of this system, which would allow the assessment of the quality for each direction of activity as well as the quality of the entire system. Aim of study. The argumentation of the principles of classification for the directions of activity of the pharmaceutical control system. Methods and materials. The legislative and sub-legislative acts (Government Decisions, Order of Ministries, Regulations, Instructions, Standards, etc.) of the Republic of Moldova in the fields of pharmaceutical activity, pharmaceutical control activity, medical control, state control served as research material. The methodology - systemic approach, methods used: analysis and synthesis, content analysis, logical analysis, functional decomposition, classification matrix. Results: Following the study, it was argued the need to apply two basic criteria for classifying the directions of activity of the pharmaceutical control system: Criterion I - by subsystems (S / S) of the pharmaceutical system: S / S of regulation, coordination and control; S / S of drug manufacturing; S / S of wholesale distribution of medicines; S / S of retail distribution of medicines (community pharmacies and pharmacies of medical institutions); S / S of drug quality control. Criterion II - according to the content of the control performed: verification of the legality of the pharmaceutical activity (founding and location of the pharmaceutical units, practice of the pharmaceutical activity, manufacture of medicines, placement of medicines on the pharmaceutical market, etc.); verification of the quality / conformity of the pharmaceutical act (compliance with the activities carried out with the rules of good practice, quality of the pharmaceutical services provided, compliance with ethical - deontological norms, etc.); verifying compliance with the rules of quality assurance and accessibility of medicines and other pharmaceutical products (storage, assortment of products, correct price formation, quality of internal pharmaceutical control, etc.). Conclusion: The principles were argued and the classification of the directions of activity of the pharmaceutical control system of the Republic of Moldova was elaborated. Based on the developed classification, the program for assessing the quality of pharmaceutical control was issued with the application of the collective expertise method. Research is still continuing.