Stability Protocol Planning Process Project Example

Black belt Six Sigma project reduced $130,000 in profitability losses--In today's pharmaceutical industry, many choices exist in both the form and packaging of drug formulations. An active pharmaceutical ingredient (API) can be made into capsules, tablets, solutions, suspensions and creams, for example. To ensure that the efficacy of the formulations will not deteriorate under various packaging and temperature/humidity environments, these formulations are subjected to stability studies, typically for 12 to 36 months. For one contract research manufacturer, the lengthy planning and approval process used to design stability protocols was eroding profits from fixed-price contracts. In conducting stability studies, drug manufacturers aim to meet governmental guidelines regarding product stability under different environmental conditions. This ensures various temperature and humidity settings do not affect physical or chemical properties of the formulation. In order to complete the studie