Using risk analysis to guide changes to compounding formulae

Abstract

“Frame formulations” are a framework for extemporaneously preparing pharmaceutical products. Alterations to the frameworks are allowed, e.g. by changing the quantity of active ingredients or by changing the percentage of excipients, as long as the variations do not affect the level of risk associated with the final product or their efficacy. Here we detail a method of analysing the risk of changes to frame formulations by assigning a risk priority number to the changes using Failure Modes Effects Analysis. The risk priority number estimates the severity and probability that changes to the formulation would have.