Assessment of the scope of testing required to qualification the BMS using FMEA methods

Abstract

In the pharmaceutical industry, BMS qualifications are carried out by applying structures models for risk management, in accordance to relevant GMP requirements. In this paper, the FMEA method of risk analysis for assessing the scope and qualification level of the BMS was applied. FMEA is a desirable method for risk management in the pharmaceutical industry because it involves improved reliability, superior quality, increased security and it is based on understanding the processes and on knowledge of the characteristics of the system itself. Through this paper potential problems are identified, the level of risk is assessed, and actions to reduce or completely eliminate risks from their impact on the BMS are proposed.