Risk Assessment of Manufacturing and Usage of Test-Systems for Quality Control of Compounded Preparations

Abstract

INTRODUCTION: The development and implementation of test systems in pharmacy practice could be one of the ways of optimization of the quality control of compounded preparations. Test kits, which have been manufactured in a pharmacy, are simple, cheap and effective for the quality control of a wide range of pharmaceutical preparations. Guidelines for quality must be taken into account during the production of such test kits to enable a pharmacist-analyst to fully perform his tasks using these analytical tools. The aim of the work is to analyze the risks that may occur during the lifecycle of test systems; to establish the risks that have the biggest impact on quality control of compounded preparations with these analytical tools and to determine the major ways to minimize the impact of risks at all stages of work with test systems. MATERIALS AND METHODS: Ishikawa diagrams and Failure Mode, Effects and Criticality Analysis (FMECA) were used to analyze the risks during the lifecycle of test systems. Data were received through "brainstorming session" and questioning respondents that were related to the development and practical use of these analytical tools. RESULTS: According to the results Risk Priority Number (RPN) for each of the stages of the lifecycle of the test systems has been calculated. The highest values of RPN are observed at the stages of manufacturing of the test systems (54.95%), the quality control (21.93%) and the use of the test systems (18.66 %). Each of the stages of the lifecycle of the test system consists of a number of phases; the most important among them are: preparation of the reagent solution-20.24%; chemical analysis-17.93%; visual fixation of results-9.21% and training of the personnel-8.89%. CONCLUSIONS: The recommendations concerning minimization of risk throughout the lifecycle of test kits were developed relying on the results. Optimization in accordance with these guideline procedures of manufacturing, quality control, storage and using these test systems allows to ultimately get high-quality analytical tools for the quality control of compounded preparations.

Quality assurance strategy of pharmacy compounded drugs

“…Запропонована стратегія забезпечення якості залежить від розуміння властивостей ЛЗ, лікарської форми, процесу виготовлення та оцінки ризиків, і забезпечує належне виконання та якість виготовлення. Дану діаграму причин та наслідків можна використовувати як шаблон для ідентифікації ризиків при виготовленні та контролі якості ЛЗАВ та при їх кількісній оцінці, що було викладено у попередніх роботах [17,18] присвячених кількісній оцінці ризиків методом аналізу режимів, наслідків і критичності відмов (Failure Mode, Effects and Criticality Analysis (FMECA)). За результатами проведених досліджень було встановлено, що у залежності від лікарської форми, умов виготовлення та ін.…”