Trending and Out-of-Trend results in pharmaceutical industry

Abstract

There are increasing demands from both, regulatory agencies and industry itself, for improving the quality monitoring procedures. This focus on quality and risk management has prompted for re-evaluation of the systems and procedures to ensure compliance with the proposed guidelines. One of the essential tools for quality monitoring is statistical tools with which we can support any conclusion with regard to the variability and capability of a given process and thus we can ensure a state of control. There are numerous techniques which can be used and one of them is Statistical Process Control (SPC). SPC is a highly structured approach for defining what is important, by process screening; data collection and measuring the data; data analyzing and finding the variations; what needs to be done and how to bring the process in control and maintain the state of control. Trending is part of SPC and enables to see the general direction towards which the process is moving. Trending is used as a prevention of possible out-of-specification results and nonconforming products that could have impact on the patient’s health. It is no longer acceptable to be only within specification limits and out of process control. Keywords: trend, trending, control charts, SPC, variable data, discrete (attribute) data, standard deviation, upper control limit, lower control limit