METHODOLOGY OF DEVELOPING A COMPLEX OF STANDARD OPERATING PROCEDURES IN CONDITIONS OF IMPLEMENTATION GOOD PHARMACY PRACTICE

Abstract

The aim of the work. Scientific and applied grounding of approaches to the development of the list of typical standard operating procedures (SOPs) and to determine the semantic content of their components to ensure proper compliance with the requirements of Good Pharmacy Practice (GPP) standards.

Materials and Methods. Laws and regulations of Ukraine and other countries, the Joint International Pharmaceutical Federation and the World Health Organization guidelines «Good Pharmacy Practice: Quality Standards of Pharmacy Services» (2011), and systemic and structural-functional analysis, including process simulation were used.

Results and Discussion. Based on the experience of using national standards of GPP on the main directions of pharmacy activity in different countries and relevant developments of domestic scientists the typology of SOPs was conducted. A list of the most common typical SOPs according to the roles of pharmacists in the pharmacy, which they perform in their daily activities was proposed. Pharmacy management decides itself on the issue of expanding the list, depending on the range of pharmaceutical services provided.

According to the results of the research, which was based on systematic, procedural and functional-role approaches to the organization of pharmaceutical activities of pharmacies, eight types of SOPs were proposed: preparatory, commodity, production, analytical, supervisory, service, educational and evaluation.

In the absence of commonly accepted procedure for the development of the SOPs, the approximate typical SOPs structure for pharmacies and its semantic content was proposed, taking into account the following requirements of GPP: relevance, clarity, accuracy, accessibility, convenient format. To ensure the availability of material, the SOP does not duplicate the basic information on the requirements for pharmaceutical activity that is placed in the standard GPP. A number of methodological approaches to the development of SOPs have been proposed to ensure proper implementation of GPP requirements.

Conclusions. Typology of SOPs was conducted. Eight types of SOPs: preparatory, commodity, production, analytical, supervisory, service, educational and evaluation – were proposed, as well as a list of the most common types of SOPs according to a functional-role approach to the development of national standards for GPP and an approximate model of SOP for pharmacies.