The Quality Target Product Profile or QTPP is a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account the safety and efficacy of the drug product.
Last week, we saw how capturing uncertainty and detectability risk brings clarity and dimension while assessing risk when used appropriately. This week, we will look at the practical aspects of process risk assessments from a different lens: that of the people executing or using these tools.
Last week we explored how the concepts we’ve been discussing in our series line up with FMEA/FMECA methodologies. This week, we’ll explore the two impostors, uncertainty and detectability risk, a little bit further.