It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.
By eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.
Change of lot or extension of reference standard shelf-life is considered low
risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.