Drug manufacturers must verify the identity of their incoming raw materials prior to release into the production process. For some, meeting this requirement involves extracting and testing samples from a small fraction of their incoming containers; for others it means testing every single package. Regardless, all find thorough and compliant material identity verification a costly exercise, with costs that span operational, personnel, facility planning, capital equipment, maintenance and consumables. Just how costly can it get?
As we trace both the apparent and hidden costs of laboratory-based identity testing, the answer may surprise you. Fortunately, the advent of new handheld verification technologies has enabled drug manufacturers to reduce production costs while simultaneously increasing productivity and decreasing risk. Enterprising pharmaceutical plant and quality managers have implemented 21 CFR Part 11-compliant instrumentation capable of performing identity testing reliably at the loading dock through packaging materials – without hiring additional expertise. Thermo Scientific TruScan is an example of just such a system. With considerable ease of implementation, global manufacturers are reporting immediate workflow benefits. Initial estimates of financial returns are on timescales as rapid as a few months from implementation.