ENHANCEMENT OF HEALTH INSPECTION IN COMPOUNDING PHARMACIES:

Improving Quality and Efficiency in Oversight and Regulation

Abstract

This study aims to improve the working tools of inspectors from compounding pharmacies within the national health surveillance system, focusing on classifying non-conformities detected during inspections by risk categories. It employed an exploratory and qualitative methodological approach, collecting data virtually through questionnaires and focus groups. The intentional sample included five inspectors selected from a group of ten experts. Additionally, secondary sources such as bibliographic research, documentary analysis, and 2019 violation reports were examined. The results addressed the main identified "non-conformities" and the challenges faced by inspectors, while also assessing the available tools. The study resulted in the development of a Standard Operating Procedure (SOP) for compounding pharmacies, including the classification of non-conformities by risk categories, whose effectiveness was tested with participants. We emphasize the need for investments in public health education policies to meet the training needs of inspectors and promote healthcare service quality.